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"storymakers": null, "score": null, "review": null, "activistThesis": { "tone": "adversarial", "notes": "Classic Scorpion Capital long-form investigative short report (366 pages, dense walls of text with embedded screenshots, FOIA snippets, interview Q&A and yellow-highlight pull-quotes). Title page is the entire SCQA in one paragraph — extraordinarily rhetorical for a research note. Filed concurrently with an FDA Citizen's Petition, which functions as the primary 'ask'. Heavy reliance on n=50 expert/employee interviews; extensive name-and-shame of executives (Aronin, Jacobs, Kapadia, Schwartz). No explicit price target or sum-of-parts; thesis is binary regulatory/commercial collapse. Uses Skilling/Enron, Insys, Shkreli/Marathon and Aduhelm as analogues. Visually plain (Arial, single-column, dense), so visual_craft_interest is low; narrative_interest is high as a specimen of short-seller report construction. Stake not disclosed beyond standard 'is short HRMY' boilerplate.", "kpisCited": [ { "detail": "$175,000/year in 2023; price hikes of 14% in 2020/2021 and 13% in 2022", "metric": "Annual price of Wakix (WAC)" }, { "detail": "30-100% per 16 physicians interviewed; ~50% per ex-territory managers; HARMONY 3 EMA data shows only 67% at year 1 and 14% at year 5", "metric": "Patient discontinuation rate" }, { "detail": "13 fatalities — 12 in foreign trials plus 1 in US EAP; 100% in the drug arm, none in placebo", "metric": "Pre-approval trial deaths" }, { "detail": "612 case reports for Wakix through Dec 31 2022, including 137 serious AEs, 64 respiratory/thoracic, 26 cardiac, 42 hospitalizations and a recent fatality", "metric": "FAERS adverse-event reports" }, { "detail": "Alleged ~40% of Wakix prescriptions are off-label, per ex-field reimbursement manager", "metric": "Off-label prescribing share" }, { "detail": "5-700 high-volume 'whale' prescribers, mostly paid speakers, drive 20-30% of total revenue", "metric": "Speaker-program revenue concentration" }, { "detail": "~4,900 in Q4 2022; suspiciously consistent net adds of 300-400/quarter", "metric": "Average patients on Wakix" }, { "detail": "Mean 100.6 ± 78.1 ng/ml in 2007 pilot study; 5/17 patients exceeded 150 ng/ml", "metric": "Pitolisant plasma level variability" }, { "detail": "5 starts in 2022 vs. 80 modafinil, 40 venlafaxine/bupropion, 30 amphetamines, 15 sodium oxybate, 8 Sunosi at one large sleep center", "metric": "Wakix new-patient starts (KOL)" } ], "closingAsk": "Scorpion is filing an FDA Citizen's Petition requesting withdrawal of Wakix approval, and asks anyone with knowledge of serious adverse events to contact the firm confidentially.", "extraction": { "at": "2026-04-22 22:24:38+00", "model": "unknown-legacy", "runId": null, "seconds": 207.33043, "promptVersion": null }, "scqaReward": "No explicit price target; the report argues 'the end is near' as the saturated rare-disease market exhausts, 30-100% discontinuation rates bite, and FDA/legal action remove the drug — implying near-total equity impairment for HRMY.", "thesisTypes": [ "fraud_exposure", "management_change", "governance_board" ], "top3Reasons": [ "Pitolisant is a cardiotoxic H3 antagonist — same QT-risk class as withdrawn Seldane, with 13 trial deaths", "FDA approval rests on sham foreign trials and a non-existent mechanism of action", "Sales depend on an alleged Insys-style speaker-program kickback scheme and 40%+ off-label prescribing" ], "scqaSituation": "Harmony Biosciences sells Wakix (pitolisant), a first-in-class H3 histamine antagonist licensed from French lab Bioprojet, priced at $175,000 per year, as its sole approved product and the entire basis of its market capitalization.", "thesisSummary": "Scorpion Capital frames Harmony Biosciences (HRMY) as a healthcare fraud built around Wakix (pitolisant), a $175,000-per-year H3 histamine antagonist licensed from small French lab Bioprojet and pushed in the US by serial bad actor Jeff Aronin — the executive Martin Shkreli credits as his inspiration. Drawing on a four-month investigation with ~50 interviews including 16 physicians, 14 ex-employees, FOIA adverse-event reports and pharmacology consultants, the report alleges pitolisant is inherently cardiotoxic (the same QT-prolongation profile that pulled Seldane), was approved via sham foreign trials in which 13 patients died in the drug arm and none in placebo, has no proven mechanism of action, and is commercially propped up by an illegal speaker-program kickback scheme and 40%+ off-label prescribing. Discontinuation rates of 30-100%, the surprise CEO resignation on Jan 6, and a saturated rare-disease market signal imminent collapse; Scorpion is filing an FDA Citizen's Petition seeking withdrawal of approval.", "primaryDemands": [ "FDA should withdraw approval of Wakix (pitolisant) — Scorpion is filing a Citizen's Petition", "Investors and regulators should investigate the alleged speaker-program kickback scheme and off-label promotion", "Sell / short HRMY ahead of an imminent commercial and regulatory collapse" ], "scqaResolution": "Scorpion is filing an FDA Citizen's Petition demanding withdrawal of Wakix's approval, soliciting confidential adverse-event reports from physicians and patients, and urging investors to reckon with the looming regulatory and Insys-style legal liability.", "thesisOneLiner": "Scorpion shorts HRMY: Wakix is a toxic, ineffective H3 antagonist propped up by sham foreign trials, an Insys-style kickback scheme, and off-label sales — collapse is imminent.", "precedentsCited": [ "Seldane (terfenadine) FDA withdrawal for cardiotoxicity / QT prolongation", "Insys Therapeutics speaker-program kickback prosecutions (Subsys)", "Aduhelm accelerated-approval controversy", "Enron / Jeff Skilling surprise CEO resignation", "Martin Shkreli / Marathon Pharmaceuticals price-gouging playbook", "Intercept Pharmaceuticals (ICPT) Ocaliva safety / short", "HHS OIG 2020 Special Fraud Alert: Speaker Programs" ], "scqaComplication": "Pitolisant is an old, failed compound that big pharma rejected for cardiotoxicity (same QT-risk class as withdrawn Seldane), approved on sham foreign trials with 13 deaths in the drug arm, has no proven mechanism, and is sold via an alleged kickback scheme.", "narrativeInterest": 4, "notableSlidePages": [ 1, 3, 16, 17, 22, 100 ], "peerCompaniesCited": [ "Jazz Pharmaceuticals (JAZZ) — Xyrem/Xywav", "Axsome Therapeutics (AXSM) — Sunosi", "Modafinil (generic)", "Bioprojet (private, France)", "Johnson & Johnson", "GlaxoSmithKline", 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These guys invented price increases. I literally learned it from them.”", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": null, "subkind": { "name": "Testimonial", "slug": "testimonial", "status": "active", "canonId": "019de52c-fc21-71b6-9ac3-8266a64945e8", "version": 1, "description": null }, "framework": null }, "subkind": "testimonial", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:37.566+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "df16a094-bb20-4ac0-a918-f326b40c3f1a", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "\"The people prescribing Wakix are the dumb doctors or they're speakers for the company, not the ones I would want my family seeing for narcolepsy...the speakers are prescribing like crazy, and I'm like, okay, how are you finding the patients?...If Wakix was going to be a hit, it would have been a hit by now...I scratch my head wondering why patients that are on it are on it.\" — Physician and professor at Stanford. \"Bro. 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I'm surprised...listen, I've worked for a lot of pharma companies, okay? 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I'm surprised...listen, I've worked for a lot of pharma companies, okay? And I've never seen the goofiness that I've seen with this company...the pressure to produce...it was just terrible. It was awful. A lot of pressure on sales, a lot of pressure on getting referrals...it was just a lot of pressure...I mean, how many cataplexy patients are there? Oh my god. How many are there? Get in no matter how you need to get in; get the referrals...I mean, as far as entertaining and speaker's programs, like these guys do - I've never seen it.", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": null, "subkind": { "name": "Testimonial", "slug": "testimonial", "status": "active", "canonId": "019de52c-fc21-71b6-9ac3-8266a64945e8", "version": 1, "description": null }, "framework": null }, "subkind": "testimonial", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:36.822+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "00b5c941-66cd-4b13-8956-83af3d601bd6", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "\"I'm surprised there hasn't been regulatory pressure put on them. 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"components": [ { "bbox": null, "kind": "callout", "text": "We encourage them to study the leaderboard of Insys prosecutions, a close analogy to Harmony’s business model vis-a-vis the False Claims Act, Anti-Kickback Statute, and other laws.", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": { "name": "Visual emphasis", "slug": "visual-emphasis", "status": "active", "bestFor": null, "canonId": "019dd9e1-474b-736b-a8eb-a794dd88241c", "version": 1, "bodyDocId": null, "description": "Drawing the eye to one element above the rest of the slide.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:25+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9cc9-fda38f94c766", "parentComponentId": null }, { "bbox": { "h": 0.15, "w": 0.86, "x": 0.07, "y": 0.75 }, "kind": "paragraph", "text": "In March 2013, a Regional Sales Manager for Insys sent an email to FREEDMAN informing him that he would receive more Speaker Programs in the coming months because Insys wanted prescriptions of Subsys to increase, and urging FREEDMAN to put more patients on Subsys. FREEDMAN responded, in part, “Got it,” and significantly increased his Subsys prescriptions in the following months, during which he received approximately $33,600 in Speaker Program fees.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:39.233+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "32436a26-4e42-43e2-bb46-cf3ee97fab74", "parentComponentId": null }, { "bbox": { "h": 0.45, "w": 0.86, "x": 0.07, "y": 0.06 }, "kind": "paragraph", "text": "John Jacobs abruptly fled as Harmony’s CEO on January 6th, throwing the company under a bus on the eve of the JP Morgan healthcare conference. The stock fell as investors wondered what he knew, and why he left for a mediocre comp package at a troubled vaccine maker (NVAX) with a fraction of the market cap. We had already been investigating HRMY for months, and chuckled as it reminded us of Jeff Skilling’s surprise resignation from Enron. Most now forget Skilling’s pathetic attempt to flee, a few months before a baffled market came to know what he did. Skilling, we note, still ended up in prison – an outcome as far from his mind as we presume it is for Harmony executives and the high-volume prescribers in its speaker’s program. We encourage them to study the leaderboard of Insys prosecutions, a close analogy to Harmony’s business model vis-a-vis the False Claims Act, Anti-Kickback Statute, and other laws.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:39.233+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "cebd8eaf-5c5f-4321-9f8b-558c1cc1d016", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "“Got it,” — Dr. Freedman (in response to an email from an Insys Sales Manager regarding speaker program fees).", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:25+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9cca-01ec696757d3", "parentComponentId": null }, { "bbox": { "h": 0.05, "w": 0.65, "x": 0.07, "y": 0.93 }, "kind": "source-note", "text": "Source: https://www.justice.gov/usao-ma/pr/founder-and-former-chairman-board-insys-therapeutics-sentenced-66-months-prison; https://www.justice.gov/usao-sdny/pr/manhattan-doctor-sentenced-more-17-years-prison-bribery-and-kickback-scheme-and", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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"For the last 8 quarters, the increase each period is 300 or 400 patients, to the penny – a curiously consistent and repetitive pattern.", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": { "name": "Visual emphasis", "slug": "visual-emphasis", "status": "active", "bestFor": null, "canonId": "019dd9e1-474b-736b-a8eb-a794dd88241c", "version": 1, "bodyDocId": null, "description": "Drawing the eye to one element above the rest of the slide.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:24+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9cc9-5d0e6d65e954", "parentComponentId": null }, { "bbox": null, "kind": "metric", "text": "Average number of patients on Wakix: 4,900", "attrs": null, "canon": { "kind": { "name": "Metric", "slug": "metric", "status": "active", "canonId": "019de52c-f923-73bf-8081-d0b1a8c5264d", "version": 1, "description": "Big-number or KPI value." }, "tool": { "name": "Quantification", "slug": "quantification", "status": "active", "bestFor": null, "canonId": "019dd9e1-47ab-72ce-a079-aab1f5299e88", "version": 1, "bodyDocId": null, "description": "Translating a claim into numbers, charts, or tables.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": "primary", "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:24+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9cc9-6160fad41e34", "parentComponentId": null }, { "bbox": { "h": 0.55, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "With Jacobs gone, Harmony is now on its third CEO. The first, Bob Repella, pled guilty and was sentenced for paying a $120K bribe to get his daughter into college. Typical of scams, the company is a revolving door of C-level executives, several of whom we spoke to. Harmony is also on its third CFO, Sandip Kapadia, with whom we are well acquainted and whose arrival at a biotech is now one of our top indicia of fraud. We’ll get to him shortly. A CEO unexpectedly resigning from a pump-and-dump is an ultra-predictive sign that the end is imminent. They usually do so to dump their stock with haste, under the cover of night without a Form 4. Harmony has secrets, and Jacobs knows what they are. So do we. The company tells investors almost nothing, demurring on basic metrics like the price of the drug, price increases, gross vs. net, refill and discontinuation rates. 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We asked again and he mumbled and froze like a deer, at which point the CEO terminated the 1x1 and escorted us to the door - the only time we have been kicked out of a meeting.", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": { "name": "Visual emphasis", "slug": "visual-emphasis", "status": "active", "bestFor": null, "canonId": "019dd9e1-474b-736b-a8eb-a794dd88241c", "version": 1, "bodyDocId": null, "description": "Drawing the eye to one element above the rest of the slide.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:25+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9cca-456e6021f199", "parentComponentId": null }, { "bbox": { "h": 0.25, "w": 0.16, "x": 0.07, "y": 0.45 }, "kind": "image", "text": "Sandip Kapadia, CPA, MBA, Chief Financial Officer", "attrs": null, "canon": { "kind": { "name": "Image", "slug": "image", "status": "active", "canonId": "019de52c-f978-701f-a720-51d029d769e7", "version": 1, "description": "Photo, illustration, screenshot or icon." }, "tool": null, "subkind": { "name": "Headshot", "slug": "headshot", "status": "active", "canonId": "019de52c-fd5f-765c-9282-38b54f61bbbf", "version": 1, "description": null }, "framework": null }, "subkind": "headshot", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:39.353+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "e6c1e7e7-04dd-4fdb-bec1-740982ce599a", "parentComponentId": null }, { "bbox": { "h": 0.32, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "Kapadia is a supporting actor who only showed up in 2021 - Harmony is strictly Jeff Aronin’s show – but when it comes to sketchy accounting and metrics, he seems to know the role. His last job was as CFO of Intercept (ICPT), another company with a toxic drug, which we shorted successfully into its garbage NASH trial a few years ago. The stock has since imploded. We had a 1x1 meeting with him and the CEO at the JPM conference, and asked about an accounting item we thought was fraudulent. He was evasive. 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"runId": null, "seconds": null, "promptVersion": null }, "componentId": "0688ca32-5146-4844-baea-c8a6c8337379", "parentComponentId": null }, { "bbox": null, "kind": "metric", "text": "Medicaid rebate accrual: $28MM", "attrs": null, "canon": { "kind": { "name": "Metric", "slug": "metric", "status": "active", "canonId": "019de52c-f923-73bf-8081-d0b1a8c5264d", "version": 1, "description": "Big-number or KPI value." }, "tool": { "name": "Quantification", "slug": "quantification", "status": "active", "bestFor": null, "canonId": "019dd9e1-47ab-72ce-a079-aab1f5299e88", "version": 1, "bodyDocId": null, "description": "Translating a claim into numbers, charts, or tables.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": "primary", "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:24+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9cc9-7a4a0166b440", "parentComponentId": null }, { "bbox": { "h": 0.45, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "The first Harmony 10K filed under his tenure – for 2021, filed in March 2022 – contained a surprise: a “Critical Audit Matter” flagged in the auditor opinion, which refers to items that are “material to the financial statements” and involve “especially challenging, subjective, or complex judgments.” It’s flagged again in the 10K last month, concerning the gross-to-net rebate accrual for Medicaid. The issue is cloaked with complexity and lack of detail, but concerns a massive rebates bucket within accrued expenses - $28MM as of 12/22. It’s impact on revenue “growth” is as hard to discern as that of price increases. Harmony conceals Wakix’s price from doctors and its own sales reps. From one state’s data, we see a WAC of $136K for 2019, $155K for 2020/2021, and $175K for 2023 – a price hike of 14% in 2020/2021 and 13% in 2022. While HRMY’s 2022 revenue grew 43%, a rough estimate – the best one can do with crumbs – suggests that volume growth was far lower at ~25%.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:40.364+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "4568cb1e-5283-41cc-a407-11ba32a78ac7", "parentComponentId": null }, { "bbox": { "h": 0.02, "w": 0.61, "x": 0.07, "y": 0.59 }, "kind": "paragraph", "text": "Rebate Accrual for Medicaid – Refer to “Note 3-Product Sales, Net” to the financial statements", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:40.364+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "9e7e21dc-7f65-4fa8-ac98-285498b05479", "parentComponentId": null }, { "bbox": { "h": 0.25, "w": 0.86, "x": 0.07, "y": 0.67 }, "kind": "paragraph", "text": "As more fully disclosed in Note 3 to the financial statements, the Company recognizes revenue on sales of WAKIX when the customer obtains control of the product, which occurs at a point in time, typically upon delivery. Product revenues are recorded at the product's wholesale acquisition costs, net of applicable reserves for variable consideration that are offered within contracts between the Company and its customers, payors, and other indirect customers relating to the sale of WAKIX. Components of variable consideration include government and commercial contracts, commercial co-payment assistance program transactions, and distribution service fees.\n\nThe rebate provision and related liability related to the Medicaid Drug Rebate Program (the “Medicaid rebate accrual”) involves the use of significant assumptions and judgments in the Company's calculation. These significant assumptions and judgements include consideration of legal interpretations of applicable laws and regulations, historical claims experience, payer channel mix, current contract prices, unbilled claims, claims submission time lags, and inventory levels in the distribution channel.\n\nGiven the complexity involved in determining the significant assumptions used in calculating the Medicaid rebate accrual, auditing these estimates involved especially subjective judgment.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:40.364+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "d88d10fe-bd06-48d2-8009-f9ac50f50bc4", "parentComponentId": null }, { "bbox": { "h": 0.02, "w": 0.57, "x": 0.07, "y": 0.94 }, "kind": "source-note", "text": "Source: Harmony 10K filing; https://www.dshs.texas.gov/prescription-drug-price-disclosure-program/data-overview", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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We've talked a lot about within this category the average discontinuation rate of drugs for the narcolepsy market range between 30% and 50% at 12 months. And then again, you may have a smaller portion of discontinuation in year two and three for chronic medications, which is consistent across the industry. 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We can locate no methodology – over what period of time is the average calculated, what does “on Wakix” mean, and has the definition ever changed? A company simply needs to disclose patients at quarter end, and the average from period to period becomes obvious. An equally material number is the refill and discontinuation rate, which the company refuses to disclose. It is an Achilles Heel – the number of patients for a rare-drug is small, and if 50% or more discontinue within weeks or months, it’s a water bucket with a giant hole. It is self-evident that no such company can survive if patients aren’t sticky. It becomes a bottle rocket with two years of growth and a sudden collapse. 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0.19 }, "kind": "paragraph", "text": "The trial followed patients for 5 years, even though the trial paper (2019) fails to disclose this fact, and nor does it show any data beyond the first year. However, an appendix buried in the EMA review for pitolisant circa 2015 contained a nugget - of 102 patients, 68 (67%) were left at 12 months, and only 44%, 37%, 33%, and 14% at years 2, 3, 4, and 5. The paper states that 90% of the patients who discontinued did so within 3 months, so the 12-month discontinuation rate of 30-50% is a 90-day figure in disguise.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:40.962+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "2545d8b7-2b91-4e2e-b912-d71693e9894b", "parentComponentId": null }, { "bbox": { "h": 0.12, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "If the 12-month discontinuation rate is 30-50%, what is it in years 2 and 3? For investors seeking a clue into Harmony’s predicament, we note HARMONY 3, a one-year foreign open-label trial, which we analyze in a later chapter.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:40.962+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "7219b6f9-ee80-48cd-b77c-e2f24207c972", "parentComponentId": null }, { "bbox": { "h": 0.1, "w": 0.86, "x": 0.07, "y": 0.63 }, "kind": "paragraph", "text": "The maximal dose received during the study was 36 mg / day in 85% of patients. After 12 months of treatment, improvements in EDS assessed by ESS score of remaining patients is of same magnitude as those observed in the other trials conducted in narcoleptic patients. 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Bioprojet’s opaque French filings suggest the drug face-planted in Europe. Wakix is a once-daily pill indicated for the treatment of excessive daytime sleepiness (EDS) and/or cataplexy in adults who have narcolepsy. We note the label’s specificity: it is not a cure for narcolepsy, a very rare disease, and merely addresses two symptoms in people with the condition.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:44.857+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "78e9b279-9b4e-4a70-8a27-ab92f1423edc", "parentComponentId": null }, { "bbox": { "h": 0.25, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "Harmony was founded in 2017 by Jeff Aronin, the company’s Executive Chairman. A family trust is the second largest holder, with 18% ownership worth ~$500MM. 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Cataplexy is vaguely defined as “sudden and transient episodes of loss of motor tone triggered by emotions.” Narcoleptics are not collapsing on the street like cataplectic goats when tickled, as attacks are brief at seconds or minutes, “self-limiting and resolve without medical attention,” often barely perceptible such as a twitch of an eyebrow, and the symptom is well-handled with SSRI’s. Second, the market for EDS - Wakix’s only other market opportunity besides cataplexy - is crowded with numerous approved drugs, such as amphetamines (Adderall), methylphenidates (Ritalin), modafinil and its variants, antidepressants like SSRI’s, sodium oxybate’s like Jazz Pharma’s Xyrem and Xywav, and solriamfetol (Sunosi). Our doctor interviews indicate no shortage of options.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:41.2+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "5728436b-8053-4216-a38b-a60bb464cfcc", "parentComponentId": null }, { "bbox": { "h": 0.02, "w": 0.6, "x": 0.07, "y": 0.94 }, "kind": "source-note", "text": "Source: http://www.sleepscience.org.br/details/401/en-US/current-and-future-treatment-options-for-narcolepsy--a-review", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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It is not a cure for narcolepsy, and of the two symptoms it is approved for, cataplexy is ultra-rare, not serious, and easily treated. That leaves EDS – excessive daytime sleepiness – which unfortunately has countless treatments. The standard of care and first-line treatment is typically modafinil, a CNS stimulant available as a generic for $10-15/month or under brand names like Provigil, or its longer-acting variant armodafinil (Nuvigil, FDA approved for EDS in narcolepsy). Doctors then step-through and/or combine anti-depressants, stimulants, and sodium oxybate. Comically, even the clinical trials show Wakix is inferior to modafinil, which leaves only one conceivable argument: that it is easier to prescribe because it's not a controlled substance, the flimsy thread by which its FDA approval, commercial pitch, and stock narrative hangs.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:40.77+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "4890094e-ddc7-4f7f-8268-42b6b9e25975", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "WAKIX is the first and only FDA-approved treatment for people with narcolepsy that is not a controlled substance. — Wakix.com", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:25+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9cca-65a61c420b5d", "parentComponentId": null }, { "bbox": { "h": 0.03, "w": 0.15, "x": 0.07, "y": 0.94 }, "kind": "source-note", "text": "Source: https://wakix.com/", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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Modafinil is schedule 4, which means a physician can write a 6 month supply – making Wakix's value proposition dubious – and even amphetamine-based stimulants can be prescribed for a 90-days. Unfortunately for Harmony, every single physician we interviewed indicated there is no value proposition to Wakix being non-controlled: 1) prescribers are already registered to write controlled substances; 2) they still have to write periodic refills for Wakix patients as it's a third or fourth line drug, almost never used as a monotherapy, and other drugs in the cocktail are controlled. And of course, as it's only a Hail Mary add-on to scheduled drugs, it's not displacing and reducing the use of any controlled substance. We preview color from a later section:", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:42.134+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "d4affd3f-323e-40c5-af94-bc0d783bbd74", "parentComponentId": null }, { "bbox": { "h": 0.13, "w": 0.86, "x": 0.07, "y": 0.47 }, "kind": "quote", "text": "\"Absolutely no benefit from it\"; \"it doesn't matter\"\n\"I don't think there's any big deal because, for me, I've still got to prescribe medicine, so I see absolutely no benefit from it... you have to prescribe something anyway; it's just a couple of clicks. So, I don't know what the big deal is...so, Wakix is less scheduled, but it doesn't matter.\" – Neurologist, sleep specialist, and professor at leading West Coast institution", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": null, "subkind": { "name": "Testimonial", "slug": "testimonial", "status": "active", "canonId": "019de52c-fc21-71b6-9ac3-8266a64945e8", "version": 1, "description": null }, "framework": null }, "subkind": "testimonial", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:42.134+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "20cf9080-2e17-4611-bea5-75ee1a0b8ebc", "parentComponentId": null }, { "bbox": { "h": 0.16, "w": 0.86, "x": 0.07, "y": 0.62 }, "kind": "quote", "text": "\"I don't see\" any value from it\n\"I prescribe a lot of scheduled—like whether it's Adderall or modafinil or like all of these. It's a little bit of a hassle because you do have to plug in an extra code when you write these controlled substances, but at the same time, as a doctor, you want to give a medication that works because then, I mean, first of all, it's about the patient. You want to improve their health. You want to improve their condition. And second of all, if you're a doctor prescribing medications that don't even work, I mean, what type of value is there? What kind of value is there? I don't see it.\" – Sleep physician in great Los Angeles area", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": null, "subkind": { "name": "Testimonial", "slug": "testimonial", "status": "active", "canonId": "019de52c-fc21-71b6-9ac3-8266a64945e8", "version": 1, "description": null }, "framework": null }, "subkind": "testimonial", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:42.134+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "45219621-9a79-40f0-880c-c3092e0ecf64", "parentComponentId": null }, { "bbox": { "h": 0.16, "w": 0.86, "x": 0.07, "y": 0.79 }, "kind": "quote", "text": "\"It's not that big a deal\"; scheduled substances can still be prescribed for up to 6 months at a time\n\"Schedule 3 and Schedule 4 can both be written with refills going as much as 6 months. My Xywav prescriptions, I have to refill twice a year, the same thing with modafinil. So, it's not nearly as onerous as Adderall, where you have to write a new script every month...Schedule 2s are more annoying. Three and 4 are the same, honestly. It's not that big a deal... most patients I treat with narcolepsy are going to be a 2 or 3-agent regimen, and those are going to involve things that are at least Schedule 4.\" – Physician and medical advisor to Harmony", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": null, "subkind": { "name": "Testimonial", "slug": "testimonial", "status": "active", "canonId": "019de52c-fc21-71b6-9ac3-8266a64945e8", "version": 1, "description": null }, "framework": null }, "subkind": "testimonial", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:42.134+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "e9c29a22-a98a-4eef-9956-bfa419ce21ac", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "“I don't think there's any big deal because, for me, I've still got to prescribe medicine, so I see absolutely no benefit from it... you have to prescribe something anyway; it's just a couple of clicks. 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Pitolisant blinds to presynaptic H3 autoreceptors... 2. Acting as an inverse agonist... 3. This increased histamine in the synapse... 4. Increased histamine binding at H1 receptors... 5. 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"status": "active", "canonId": "019de52c-fd87-7509-8391-3d79fb339379", "version": 1, "description": null }, "framework": null }, "subkind": "screenshot", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:42.594+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "cbeab39a-b763-4141-a619-6ca044ce8c8f", "parentComponentId": null }, { "bbox": { "h": 0.35, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "Pitolisant is the first and only H3 receptor antagonist/inverse agonist on the market for a reason – virtually every major pharma company tried to develop one for decades, with a 100% failure rate due to a fatally flawed mechanism of action and pharmacokinetic profile, lack of efficacy, and toxicity. The elephant in the room is self-evident: how did a small French lab miraculously succeed when over a dozen global pharma players failed, and why did no other pharma company license it until Jeff Aronin came along? Pitolisant’s structure was published in 2002 and we think it was first synthesized in the 1990’s, meaning it sat for a quarter-century with no takers. The compound is so old that the three patents Harmony asserts are a sham. We located a 2002 paper that published the molecule’s structure under a different name, creating prior art that would instantly invalidate the IP if we challenged in an Inter Partes Review.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:42.594+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "0ba31fb0-6fa4-463a-94cf-67bd84777c67", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "Jean-Charles Schwartz paper submitted for publication in 2001 - table shows same molecule as pitolisant", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:25+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9cca-ad5f550e2c1d", "parentComponentId": null }, { "bbox": { "h": 0.03, "w": 0.25, "x": 0.07, "y": 0.95 }, "kind": "source-note", "text": "Source: https://pubmed.ncbi.nlm.nih.gov/11855993/", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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"h": 0.52, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "Harmony has no intellectual property, which is besides the point as no reputable pharma company would market a drug this toxic and risk existential tort litigation, but at the very least it removes any possibility of acquisition – already remote as the 3 US patents expire in 3, 6, and 7 years, respectively. We nonetheless asked a biotech IP litigator – someone with decades of experience and who we have consulted for years – to review each US patent. Bioprojet knew that their prior publication of the molecule’s structure would be problematic, and hence asserted in the US patents that they had invented a novel salt of the molecule – pitolisant hydrochloride – and that the previous molecule was merely a base. The lawyer indicated the tactic is spurious and that an IPR would be prejudicial against the company, as it establishes an attempt to mislead the patent office. He stated it is damning that the authors on the US patents are the same as the ones in the 2002 paper; and that even then, PubChem shows the patented salt published as prior art in 2006, and perhaps earlier if one commissions a search from the American Chemical Society’s database.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:41.955+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "ca77a517-49c7-4554-aa14-c7792dff3a8e", "parentComponentId": null }, { "bbox": { "h": 0.03, "w": 0.75, "x": 0.07, "y": 0.95 }, "kind": "source-note", "text": "Source: https://patentimages.storage.googleapis.com/ca/f6/6a/aa89c81f61fd29/US8207197.pdf; https://pubchem.ncbi.nlm.nih.gov/#query=pitolisant%20hydrochloride", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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typical of a Jeff Aronin rig.", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": { "name": "Visual emphasis", "slug": "visual-emphasis", "status": "active", "bestFor": null, "canonId": "019dd9e1-474b-736b-a8eb-a794dd88241c", "version": 1, "bodyDocId": null, "description": "Drawing the eye to one element above the rest of the slide.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:25+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9ccb-1bc6c519d6c2", "parentComponentId": null }, { "bbox": { "h": 0.35, "w": 0.28, "x": 0.07, "y": 0.53 }, "kind": "image", "text": "Jeff Aronin, Harmony founder and executive chairman", "attrs": null, "canon": { "kind": { "name": "Image", "slug": "image", "status": "active", "canonId": "019de52c-f978-701f-a720-51d029d769e7", "version": 1, "description": "Photo, illustration, screenshot or icon." }, "tool": null, "subkind": { "name": "Headshot", "slug": "headshot", "status": "active", "canonId": "019de52c-fd5f-765c-9282-38b54f61bbbf", "version": 1, "description": null }, "framework": null }, "subkind": "headshot", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:41.912+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "faf005f0-6bcb-4385-8aad-d96278b38cc6", "parentComponentId": null }, { "bbox": { "h": 0.15, "w": 0.56, "x": 0.37, "y": 0.53 }, "kind": "other", "text": "Carter-Wallace Issues Epilepsy Drug Warning. NEW YORK — Drug maker Carter-Wallace Inc. told doctors Monday to take their patients off the epilepsy drug Felbatol after two people who took it died from a serious form of anemia, a development that led to the company’s stock losing a third of its value.", "attrs": null, "canon": { "kind": { "name": "Other", "slug": "other", "status": "active", "canonId": "019de52c-fa90-743c-8bf6-20d1fbe82b6d", "version": 1, "description": "Fallback when no canonical kind applies." }, "tool": null, "subkind": { "name": "Unclassified", "slug": "unclassified", "status": "active", "canonId": "019de52d-05ca-77db-81fb-db7d4234bbc0", "version": 1, "description": null }, "framework": null }, "subkind": "unclassified", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:41.912+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "c997ec06-6618-4372-8249-8952a427cd3d", "parentComponentId": null }, { "bbox": { "h": 0.25, "w": 0.86, "x": 0.07, "y": 0.22 }, "kind": "paragraph", "text": "He was interviewed by a local radio station in 2021, where he stated his first job out of college was selling a pediatric epilepsy drug for Carter-Wallace. The interviewer notes that “he was upset to see the company pull off the market a therapy that...helped many families because a side effect was discovered.” We presume the drug was felbatol, which was implicated in fatalities and remains one of the most infamous cases of post-approval toxicity. It is one thing to be a naïve drug rep in his early 20’s – quite another to be a 55-year old who still has a grudge about it.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:41.912+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "9db9f6b9-d6f4-4ad3-a322-3b69038d5785", "parentComponentId": null }, { "bbox": { "h": 0.15, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "A biotech with no IP is, of course, a house of cards - typical of a Jeff Aronin rig. Aronin is a serial biotech promoter with a notorious history. His fetish for dressing up and pushing toxic CNS drugs seems to have begun in his youth.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:41.912+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "b40ecb33-8613-4f12-9b11-63c915c1b414", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "he was upset to see the company pull off the market a therapy that...helped many families because a side effect was discovered. — Interviewer (referencing Jeff Aronin)", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:25+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9ccb-1d2953f6df0c", "parentComponentId": null }, { "bbox": { "h": 0.05, "w": 0.55, "x": 0.07, "y": 0.92 }, "kind": "source-note", "text": "Source: https://www.wuwm.com/2021-08-25/how-jeff-aronin-began-building-life-sciences-companies-and-never-stopped; https://www.latimes.com/archives/la-xpm-1994-08-02-fi-22645-story.html", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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"/slides/019dd923-622c-750b-8b9a-21918ac10c17/34", "deck": "/decks/019dd923-622c-750b-8b9a-21918ac10c17", "deckAnchor": "/decks/019dd923-622c-750b-8b9a-21918ac10c17#slide-34", "deckJson": "/decks/019dd923-622c-750b-8b9a-21918ac10c17.json" }, "components": [ { "bbox": null, "kind": "callout", "text": "Aronin’s bio’s, websites, and his LinkedIn profile all avoid mention of Marathon Pharmaceuticals, which he founded a decade ago.", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": { "name": "Visual emphasis", "slug": "visual-emphasis", "status": "active", "bestFor": null, "canonId": "019dd9e1-474b-736b-a8eb-a794dd88241c", "version": 1, "bodyDocId": null, "description": "Drawing the eye to one element above the rest of the slide.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, 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The company spent $370K to license old clinical data, from the 1990’s in the UK, for a Duchenne Muscular Dystrophy drug called deflazacort, a cheap generic sold for ~$1,000/year, and used it to get FDA approval without running any trials. The day it was approved, Marathon raised the price by ~90 times to $89,000 versus the price US families paid an online UK pharmacy. The WSJ, in a detailed investigative piece, stated “the company didn’t do the late-stage clinical trials needed to win FDA approval to market deflazacort. 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A European KOL called him “crazy,” but demurred when we asked for specifics. Others were more forthcoming, such as a scientist who spent decades at a global pharma company, publishing hundreds of papers including foundational work on the H3 receptor. His knowledge of pitolisant was in-depth, and he described his interactions with Schwartz - “an odd sort of guy” - and recounted a story of his shouting from the audience at presenters at conferences – “It was bizarre. I’d never come across that before.” He described him as paranoid and “getting into screaming matches” and “shouting matches” with scientists at international meetings – “he did it to somebody from Novo Nordisk”; “he attacked a guy from GSK…it’s just insane.”", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:43.866+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "f747c1ab-9c83-4587-9f41-789ea92f8490", "parentComponentId": null }, { "bbox": { "h": 0.3, "w": 0.86, "x": 0.07, "y": 0.63 }, "kind": "quote", "text": "“That would describe Jean-Charles. It was really fundamental research that he published. But then, after a while, it’s like, well, so what? It was a great discovery, but it doesn’t make you a pharmaceutical company, right? When I showed up, the first talk I gave was in the Netherlands on what we were doing…and at the end of the talk, he shouted from the audience. He said how can I have the nerve to come to Europe and not acknowledge all the work that they did? And I was just stealing all their science. He did that in a public forum. And he did it to somebody from Novo Nordisk, who was talking in the lecture before and then two years later, he attacked a guy from GSK. It’s just insane. And I’d never had this at a scientific meeting…there was a degree of arrogance there.. It was bizarre. I’d never come across that before…he was always very dismissive of other pharmaceutical companies, and I had a couple of shouting matches with him over some of the science because he felt he was the owner of H3. He had actually—he characterized the receptor. He got two nice papers in Nature, I believe. But he was a—I don’t want to be pejorative about—he had this arrogance about him… When pitolisant came out—I remember going to international meetings and getting into screaming matches with these guys because they felt they had everything and all the big pharma companies would rip them off, which was not the case—Ex-longtime senior scientist at Johnson & Johnson, with global leadership roles in neuroscience", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": null, "subkind": { "name": "Testimonial", "slug": "testimonial", "status": "active", "canonId": "019de52c-fc21-71b6-9ac3-8266a64945e8", "version": 1, "description": null }, "framework": null }, "subkind": "testimonial", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:43.866+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "de1dbf0f-59fb-4d51-bda7-8afda37a503c", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "“That would describe Jean-Charles. It was really fundamental research that he published. But then, after a while, it’s like, well, what? It was a great discovery, but it doesn’t make you a pharmaceutical company, right? When I showed up, the first talk I gave was in the Netherlands on what we were doing…and at the end of the talk, he shouted from the audience. He said how can I have the nerve to come to Europe and not acknowledge all the work that they did? And I was just stealing all their science. He did that in a public forum. And he did it to somebody from Novo Nordisk, who was talking in the lecture before and then two years later, he attacked a guy from GSK. It’s just insane. And I’d never had this at a scientific meeting…there was a degree of arrogance there.. It was bizarre. I’ve never come across that before…he was always very dismissive of other pharmaceutical companies, and I had a couple of shouting matches with him over some of the science because he felt he was the owner of H3. He had actually—he characterized the receptor. He got two nice papers in Nature, I believe. But he was a—I don’t want to be pejorative about—he had this arrogance about him… When pitolisant came out—I remember going to international meetings and getting into screaming matches with these guys because they felt they had everything and all the big pharma companies would rip them off, which was not the case” — Ex-longtime senior scientist at Johnson & Johnson, with global leadership roles in neuroscience", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:27+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9ccc-ba6e71192d6b", "parentComponentId": null }, { "bbox": { "h": 0.02, "w": 0.3, "x": 0.07, "y": 0.95 }, "kind": "source-note", "text": "Source: Scorpion Capital consultation calls with experts", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. Numbered footnotes use attrs.numbered." }, "tool": null, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:43.866+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "f750659a-1573-467d-b1f9-d4edccfc3fae", "parentComponentId": null }, { "bbox": { "h": 0.03, "w": 0.25, "x": 0.07, "y": 0.59 }, "kind": "title", "text": "Anecdotes of Schwartz’s behavior", "attrs": null, "canon": { "kind": { "name": "Title", "slug": "title", "status": "active", "canonId": "019de52c-f7dd-76d9-b848-b1f12bd85cf4", "version": 1, "description": "Slide title or headline." }, "tool": null, "subkind": { "name": "Subtitle", "slug": "subtitle", "status": "active", "canonId": "019de52c-fb09-739d-900c-815b0d9ac526", "version": 1, "description": null }, "framework": null }, "subkind": "subtitle", "groupRole": null, "confidence": null, "extraction": { "at": 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Yet the paper is written to convey the impression that the average plasma level is far lower: “the plasma level average 100.6 + 78.1 ng/mL (n=17).”", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:43.579+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "59ef1b6b-4aad-40e3-889c-a3cf80e2cae0", "parentComponentId": null }, { "bbox": { "h": 0.15, "w": 0.86, "x": 0.07, "y": 0.8 }, "kind": "paragraph", "text": "Tiprolisant dosages were performed at the end of the treatment period with a median sampling time at 3.75 h after the last drug intake. The plasma level average 100.6±78.1 ng/ml (n=17). Elevated plasma levels (>150 ng/ml) were observed in 5 patients, in some cases related to the experience of adverse events occurring a few hours after drug intake.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:43.579+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "d01c0b82-4e39-4bc8-a8ac-07d7d4429153", "parentComponentId": null }, { "bbox": { "h": 0.15, "w": 0.86, "x": 0.07, "y": 0.52 }, "kind": "paragraph", "text": "Note the insertion of “n=17” – in other words, the study had 22 patients, but Bioprojet excluded the five with plasma levels >150 ng/mL in the calculation, making it impossible to deduce how high it went – as absurd as a fund manager reporting average returns but excluding the five biggest losers.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:43.579+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "ee10f10b-60a8-45b9-98e9-9dd11b69f181", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "the plasma level average 100.6 + 78.1 ng/mL (n=17). — 2007 Pilot Study", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:26+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9ccb-effa1fd0d77a", "parentComponentId": null }, { "bbox": { "h": 0.03, "w": 0.3, "x": 0.07, "y": 0.96 }, "kind": "source-note", "text": "Source: https://pubmed.ncbi.nlm.nih.gov/18295497/", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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We spoke with an ex-employee in France, who stated Bioprojet hadn’t been able to make payroll for two months and staff were leaving. He was involved in monitoring clinical trial sites, including HARMONY 3, a key trial in support of FDA approval – and the color he provided was explosive. He stated that a significant percentage of patients in HARMONY 3 presented elevated liver enzymes – consistent with the experience of other H3 programs; that two trial investigators escalated the issue, which occurred at “three or four sites”; that he then escalated it to Bioprojet “upper management,” who were “worried” as it could put their pending EMA application at risk; and that Bioprojet decided to prematurely halt the study for the “welfare of the patients.” The trial was packaged neatly into a paper that makes no mention of the alleged hepatic signal and early termination, and declared a success. We first note the ex-employee’s role, and then share detailed color on the next pages:", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:43.229+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "6d1bbfdc-ca18-4383-af16-e5ce2234e9a3", "parentComponentId": null }, { "bbox": { "h": 0.25, "w": 0.86, "x": 0.07, "y": 0.65 }, "kind": "quote", "text": "I worked on Harmony 3. I also worked on the study on [redacted]. I took part in the regulatory submission at the beginning of the project—I took part in the management of a different CRO, responsible for the management of the study...I worked with the hospital [redacted] in South of France, and I worked with a clinic in [redacted]. I worked in one hospital in [redacted]. And I worked with one hospital in [redacted] near Paris. I worked with [redacted] in Paris. I think that’s it. There were seven sites, but I remember all of the sites. We worked with Dr. [redacted], and we worked with Dr. [redacted] who is a very important doctor in the discipline.", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": null, "subkind": { "name": "Testimonial", "slug": "testimonial", "status": "active", "canonId": "019de52c-fc21-71b6-9ac3-8266a64945e8", "version": 1, "description": null }, "framework": null }, "subkind": "testimonial", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:43.229+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "8b389b17-a603-4a83-84a6-be831ea8b14a", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "I worked on Harmony 3. I also worked on the study on [redacted]. It was another study in the nervous system. In fact, this study occurred in France. We used to work with [redacted]. I also worked on another study beginning with [redacted]. But the last study, which I speak about, where the studies are in the starting phase. In fact, I took part in the regulatory submission at the beginning of the project—I took part in the management of a different CRO, responsible for the management of the study...I worked with the hospital [redacted] in South of France, and I worked with a clinic in [redacted]. I worked in one hospital in [redacted]. And I worked with one hospital in [redacted] near Paris. I worked with [redacted] Paris. I think that's it. There were seven sites, but I remember all of the sites. We worked with Dr. [redacted], and we worked with Dr. [redacted] who is a very important doctor in the discipline. — Former Bioprojet employee", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:26+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9ccc-03dda9c8c229", "parentComponentId": null }, { "bbox": { "h": 0.03, "w": 0.3, "x": 0.07, "y": 0.95 }, "kind": "source-note", "text": "Source: Scorpion Capital consultation calls with experts", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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And the other was—the site where the problem was observed was [redacted] with Dr. [redacted]”\nQ: “And what did she say about the drug?”\nA: “She decided to review the calibration of the machine to be sure that the bad blood result observed was due to the product. She asked for a plan and the upper management of Bioprojet decided to stop the study.”\nQ: “What was her reaction?”\nA: “You know it was a difficult moment because we were trying to get the marketing authorization. The upper management of Bioprojet was worried about that. To protect the welfare of the patients, it was decided to stop the study. But because the marketing authorization was in danger.”\nQ: “And what do the doctors say when they brought it up? They said I have these blood results - they don't look good?”\nA: “The bad result was declared as an adverse event. At first, they decided to review the calibration of the machine to be sure the problem did not occur from the machine. But when it had been confirmed that, in fact, the bad blood result was observed - it was to report it, they asked us, Bioprojet for a plan but Bioprojet, they decided to stop the study.”\nQ: “So, what did the doctors say? They said the patient is having blood problems - I'm worried?”\nA: “Yes, they sent an alert about the problem. They said we observed a bad blood result. What is your decision?” – Former Bioprojet employee", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:44.536+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "0af958a2-a301-4c1f-9cc0-87ca1f53773d", "parentComponentId": null }, { "bbox": { "h": 0.35, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "The ex-employee stated that 8 patients out of 102 on pitolisant exhibited the issue. He was not able to recall which enzyme or details of the labwork, given the trial was conducted 2011-2016 per ClinicalTrials.gov. The expert was a French speaker whose English was mediocre, but we view the information as credible as his color regarding which trial sites and investigators reported the adverse event was specific, as were his recollections of meetings with Bioprojet management. He stated the investigators checked the calibration of their lab equipment to verify the finding, and then pressed Bioprojet for a plan and a decision – “it was a difficult moment because we were trying to get the [EMA] marketing authorization...upper management was worried about that...to protect the welfare of the patients, it was decided to stop the study....but because the marketing authorization was in danger.”", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:44.536+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "542875a3-97bf-4b1d-a151-34740abd3854", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "“You know it was a difficult moment because we were trying to get the marketing authorization. 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Former Owner of Sleep Study Clinics Pleads Guilty to Fraud, Tax Charges. Two Charged with Running $11 Million Sleep Study Scam that Billed UPS and Costco Health Care Benefit Programs for Unneeded Tests", "attrs": null, "canon": { "kind": { "name": "List", "slug": "list", "status": "active", "canonId": "019de52c-f94b-779b-a53b-fd4904a5f4d2", "version": 1, "description": "Bullet or numbered list." }, "tool": null, "subkind": { "name": "Bullet list", "slug": "bullet", "status": "active", "canonId": "019de52c-fc98-7169-a083-5cab805076ca", "version": 1, "description": null }, "framework": null }, "subkind": "bullet", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:44.677+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "46d83af9-37fe-4e82-a8b9-9e2335fe8d4b", "parentComponentId": null }, { "bbox": { "h": 0.35, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "The sleep space has long been known as a cesspool for reimbursement fraud for sleep-test studies or sleep therapy equipment, with one DOJ prosecution after another and has been highlighted in reports by the HHS Office of Inspector General as one of the worst pockets of billing abuses. The #1 recipient of payments from Harmony is Haramandeep Singh, who we believe to one of their highest volume prescribers and most prolific speakers. In 2010, a “Dr. Haramandeep Singh dba Sleep Medicine Specialists of California” was one of several defendants named in a qui tam action pursuant to the False Claims Act. The primary defendant (not Singh) settled for $11MM with the DOJ, and claims against Singh and the other defendants appear to have been dismissed.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:44.677+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "7e31cdc0-971c-44e7-b1ad-eeedbd98a807", "parentComponentId": null }, { "bbox": { "h": 0.06, "w": 0.75, "x": 0.07, "y": 0.92 }, "kind": "source-note", "text": "Source: https://www.justice.gov/opa/pr/oxygen-equipment-provider-pays-114-million-to-resolve-false-claims-act-allegations; https://www.govinfo.gov/content/pkg/USCOURTS-cand-4_10-cv-04597/pdf/USCOURTS-cand-4_10-cv-04597-0.pdf; https://www.justice.gov/usao-cdca/pr/two-charged-running-11-million-sleep-study-scam-billed-ups-and-costco-health-care-benefit-programs-for-unneeded-tests;", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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HARAMANDEEP SINGH, D.B.A. SLEEP MEDICINE SPECIALISTS OF CALIFORNIA, Defendants.", "attrs": null, "canon": { "kind": { "name": "Table", "slug": "table", "status": "active", "canonId": "019de52c-f9c8-7148-8119-eaac9594cd28", "version": 1, "description": "Tabular data layout." }, "tool": null, "subkind": { "name": "Data table", "slug": "data", "status": "active", "canonId": "019de52d-02d5-75b8-8abf-88e92bf63569", "version": 1, "description": null }, "framework": null }, "subkind": "data", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:44.677+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "8f9e2f95-2487-4756-98c8-3a9efe279b74", "parentComponentId": null } ], "metrics": [], "tools": [], "frameworks": [ { "matchId": "728bd3c0-b804-4ff1-88d0-63c181f73380", "evidence": "The slide explicitly links a specific individual to a qui tam action and DOJ settlement to expose potential 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null, "framework": null }, "subkind": "source-note", "groupRole": null, "confidence": null, "extraction": { "at": "2026-07-17 03:28:58.224+00", "model": "google/gemini-3.1-flash-lite-preview", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "21525e22-7c86-4f99-894a-76153f721798", "parentComponentId": null }, { "bbox": { "h": 0.45, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "The recklessness that high volume Wakix prescribers exhibited in our interviews was jarring, a reflection of the false sense of safety created by Harmony’s sales practices. The FDA erred in approving the drug, but still slipped in a few watered-down warnings that understate the risk. However, one speaker after another told us they ignore them entirely. The clear pattern of the drug’s toxicity, combined with extensive comorbidities in narcoleptics like obesity, diabetes, and cardiac issues, sets the stage for disaster. We quote two prolific speakers near the top of the OpenPayments list, who stated they are most responsible for educating doctors in the US about Wakix, and whose comments are representative. The first: “those items are just warnings...you’re not going to run into those issues hardly ever”; “I’ve never ordered an EKG...that’s what I tell doctors, these are just warnings...technically speaking, you don’t have to do anything...you can just prescribe it, which is what we do.” A second: “I do not run any EKG’s...I don’t check lab work...remember, most narcoleptics are...pretty damned healthy...”", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": null, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-07-17 03:28:58.224+00", "model": "google/gemini-3.1-flash-lite-preview", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "7430c575-8c2b-4a68-83f8-0514972300f6", "parentComponentId": null }, { "bbox": { "h": 0.18, "w": 0.86, "x": 0.07, "y": 0.58 }, "kind": "quote", "text": "Bay Area-based speaker: \"Those items are just warnings. 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That's what I tell doctors; these are just warnings...\"", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": null, "subkind": { "name": "Testimonial", "slug": "testimonial", "status": "active", "canonId": "019de52c-fc21-71b6-9ac3-8266a64945e8", "version": 1, "description": null }, "framework": null }, "subkind": "testimonial", "groupRole": null, "confidence": null, "extraction": { "at": "2026-07-17 03:28:58.224+00", "model": "google/gemini-3.1-flash-lite-preview", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "70ec37cf-4714-4b4e-92c2-9b6e6596dfcb", "parentComponentId": null }, { "bbox": { "h": 0.15, "w": 0.86, "x": 0.07, "y": 0.79 }, "kind": "quote", "text": "Alabama-based speaker: \"I do not run any EKG's. When a patient says they've got things that are like palpitations or they feel dizzy... 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Remember, most narcoleptics that we see are pretty damned healthy people.\"", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": null, "subkind": { "name": "Testimonial", "slug": "testimonial", "status": "active", "canonId": "019de52c-fc21-71b6-9ac3-8266a64945e8", "version": 1, "description": null }, "framework": null }, "subkind": "testimonial", "groupRole": null, "confidence": null, "extraction": { "at": "2026-07-17 03:28:58.224+00", "model": "google/gemini-3.1-flash-lite-preview", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "9c80e711-c12b-47e7-89e9-4748098db37a", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "“Those items are just warnings...you're not going to run into those issues hardly ever”; “I’ve never ordered an EKG...that’s what I tell doctors, these are just 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TdP is associated with QTc prolongation, which is the heart-rate-adjusted lengthening of the QT interval. QT prolongation is one of the most infamous adverse drug reactions taught in pharmacy curricula because it can lead to sudden cardiac death. Drug-induced prolonged repolarization of the heart is represented by a prolonged QT interval and can predispose a patient to develop this life-threatening arrhythmia. There is no threshold of QTc prolongation at which TdP is certain to occur. A QTc greater than 500 milliseconds (ms) has been associated with a twofold to threefold higher risk for TdP, and each 10-ms increase contributes to approximately a 5% to 7% exponential increase in risk. QT prolongation can increase hospital length of stay and all-cause mortality in patients. In addition, many drugs have the potential to cause QT prolongation and/or TdP, either alone or in a drug interaction situation.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:48.85+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "350e62bb-31f6-407b-80fd-38ffed093cef", "parentComponentId": null }, { "bbox": { "h": 0.18, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "The literature on drug-induced hERG blockade and QT prolongation is extensive: “QT prolongation is one of the most infamous adverse drug reactions taught in pharmacy curricula because it can lead to sudden cardiac death.” Another paper indicates that “there is no threshold of QTc prolongation at which TdP [Torsades de Pointes] is certain to occur, and that each 10-ms increase in the QT interval contributes “to approximately 5% to 7% exponential increase in risk.”", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:48.85+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "53583ae1-796a-4dbb-93c8-03633a2f4191", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "QT prolongation is one of the most infamous adverse drug reactions taught in pharmacy curricula because it can lead to sudden cardiac death. — Literature excerpt", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:27+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9ccc-8b79fe34d70a", "parentComponentId": null }, { "bbox": { "h": 0.02, "w": 0.35, "x": 0.07, "y": 0.94 }, "kind": "source-note", "text": "Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5481298/", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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"locked": true }, { "page": 51, "type": "tension", "title": "The slide uses a quote from a 2004 NEJM paper to establish a precedent of drug withdrawal, then links the molecular structure (piperidine ring) and receptor act", "function": "name_villain", "rawType": "villain_critique", "block": null, "metadata": { "slideType": "villain_critique", "slideTypeCanon": { "name": "Villain critique", "slug": "villain_critique", "status": "active", "canonId": "019de52d-10bc-7136-bf20-09de59d17447", "version": 1, "description": null }, "function": "name_villain", "functionCanon": { "name": "Name villain", "slug": "name_villain", "status": "active", "canonId": "019de52d-1746-70d6-bc58-5eeaf5865526", "version": 1, "description": null }, "density": "dense", "densityScore": 59, "componentCount": 6, "textChars": 2174, "nDataPoints": 9, "notes": "The slide uses a quote from a 2004 NEJM paper to establish a precedent of drug withdrawal, then links the molecular structure (piperidine ring) and receptor 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Two of the nine were histamine receptor antagonists, as is pitolisant, and the molecular structure of all three is defined by a piperidine ring, the significance of which we shall explain. Most of the others that were recalled also have other troubling similarities to Harmony’s drug. Another four of the nine either involved histamine antagonist activity or targeted adjacent neurotransmitters: droperidol was a dopamine receptor antagonist but had histamine antagonist activity; sertindole was a dopamine and serotonin antagonist; cisapride was a serotonin receptor antagonist; and lidoflazine, which contained a piperazine ring in its molecular structure - closely related to the piperidine ring in pitolisant and which has similar binding behavior.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 21:26:48.831+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "2c16aa33-b535-4908-a504-dc1ef8648ee4", "parentComponentId": null }, { "bbox": { "h": 0.32, "w": 0.86, "x": 0.07, "y": 0.58 }, "kind": "quote", "text": "IN THE PAST DECADE, THE SINGLE MOST COMMON CAUSE OF THE WITHDRAWAL OR RESTRICTION OF THE USE OF DRUGS THAT HAVE ALREADY BEEN MARKETED HAS BEEN THE PROLONGATION OF THE QT INTERVAL ASSOCIATED WITH POLYMORPHIC VENTRICULAR TACHYCARDIA, OR TORSADE DE POINTES (FIG. 1), WHICH CAN BE FATAL.1 NINE STRUCTURALLY UNRELATED DRUGS THAT WERE MARKETED IN THE UNITED STATES OR ELSEWHERE FOR A RANGE OF NONCARDIOVASCULAR INDICATIONS HAVE BEEN REMOVED FROM THE MARKET OR HAD THEIR AVAILABILITY SEVERELY RESTRICTED BECAUSE OF THIS RARE FORM OF TOXICITY. THESE DRUGS ARE TERFENADINE, ASTEMIZOLE, GREPAFLOXIN, TERODILINE, DROPERIDOL, LIDOFLAZINE, SERTINDOLE, LEVOMETHADYL, AND CISAPRIDE.", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": null, "subkind": { "name": "Pull quote", "slug": "pull-quote", "status": "active", "canonId": "019de52c-fbf9-76fe-97e1-a0b7540445c9", "version": 1, "description": null }, "framework": null }, "subkind": "pull-quote", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 21:26:48.831+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "cb49e844-725f-45f3-bf37-f60070922e42", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "IN THE PAST DECADE, THE SINGLE MOST COMMON CAUSE OF THE WITHDRAWAL OR RESTRICTION OF THE USE OF DRUGS THAT HAVE ALREADY BEEN MARKETED HAS BEEN THE PROLONGATION OF THE QT INTERVAL ASSOCIATED WITH POLYMORPHIC VENTRICULAR TACHYCARDIA, OR TORSADE DE POINTES (FIG. 1), WHICH CAN BE FATAL. — NEJM (2004)", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:27+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9ccc-cca7a8c3d2c6", "parentComponentId": null }, { "bbox": { "h": 0.04, "w": 0.5, "x": 0.07, "y": 0.94 }, "kind": "source-note", "text": "Source: https://www.washingtonpost.com/archive/politics/1997/12/30/seldane-to-be-taken-off-us-market-by-maker/69d37826-3c40-49b1-8167-06c9c8b191b0/", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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This is particularly well-known for histamine receptor antagonists, e.g., the potent human ether-à-gogo-related gene (hERG) channel blocker Terfenadine (Teldane®, Seldane®). Terfenadine is an H1 receptor 1996; Fenichel et al., 2004; Gintant et al., 2011), but hERG channel blockade has become the most frequent single cause for drug withdrawals (Fenichel et al., 2004), and many drug discovery programs have been delayed (imposing significant costs on the pharmaceutical company) or stopped due to hERG channel liabilities of potential drug candidates. Bahl et al., 2012; Becknell et al., 2012; Hudkins et al., 2012; Moorthy et al., 2014). While compounds from very different chemical classes may interact with the hERG channel due to its relatively large hydrophobic pore, the property of hERG channel liability has been observed especially often for histamine receptor antagonists. 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null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:46.421+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "5c7b97b6-cdd0-4c67-a750-40a77a2767a6", "parentComponentId": null }, { "bbox": { "h": 0.18, "w": 0.86, "x": 0.07, "y": 0.72 }, "kind": "paragraph", "text": "The histamine H3 receptor (H3R) plays a regulatory role in the presynaptic release of histamine and several other neurotransmitters, and it is an attractive target for central nervous 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The development of H3R antagonists was complicated by the similarities between the pharmacophores of H3R and human Ether-à-go-go related gene (hERG) channel blockers, a fact that probably prevented promising compounds from being progressed into the clinic. 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a second basic site, (2) a polar group, (3) a lipophilic region, or (4) an acidic group, resulting in pharmacophores that comprise significant similarity to the predicted pharmacophore for hERG blockers (Fig. 1). As an example, Abbott's preclinical candidate ABT-239 (Table 1) is reported to exhibit strong binding to the hERG K+ channel (Ki = 0.45 nM; 420-fold selectivity H3R/hERG), which manifests itself in a dose-dependent QTc prolongation in dog (Altenbach, personal communication) and monkey.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:46.904+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "0fbbd0f6-9ef1-4bbd-a2f8-869196438162", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "Compounds that inhibit the H3R with high affinity contain a basic amine linked to an aromatic or general lipophilic region that is connected to either (1) a second basic site, (2) a polar group, (3) a lipophilic region, or (4) an acidic group, resulting in pharmacophores that comprise significant similarity to the predicted pharmacophore for hERG blockers (Fig. 1). — Scientific paper excerpt", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:27+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9ccc-e6fc49f22ab0", "parentComponentId": null }, { "bbox": { "h": 0.05, "w": 0.6, "x": 0.07, "y": 0.9 }, "kind": "source-note", "text": "Fig. 1. Comparison of the hERG and H3R pharmacophore models for nonimidazole H3R antagonists shown on the right. On the left, ABT-239 is docked into the hERG pore to show where the three main pharmacophore points are located. hERG, human Ether-à-go-go related gene channel; H3R, histamine H3 receptor.", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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The medical chemistry literature is unequivocal in highlighting piperidine’s propensity to cause hERG blockade.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:47.186+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "0ebcfcf6-e64e-4ca3-8529-24fcdfffc569", "parentComponentId": null }, { "bbox": { "h": 0.03, "w": 0.55, "x": 0.07, "y": 0.95 }, "kind": "source-note", "text": "Source: https://en.wikipedia.org/wiki/Piperidine; https://commons.wikimedia.org/wiki/File:Pitolisant-structure.png", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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"active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": { "name": "Visual emphasis", "slug": "visual-emphasis", "status": "active", "bestFor": null, "canonId": "019dd9e1-474b-736b-a8eb-a794dd88241c", "version": 1, "bodyDocId": null, "description": "Drawing the eye to one element above the rest of the slide.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:28+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9ccd-e43a36cc556a", "parentComponentId": null }, { "bbox": null, "kind": "metric", "text": "hERG liability probability: 94%", "attrs": null, "canon": { "kind": { "name": "Metric", "slug": "metric", "status": "active", "canonId": "019de52c-f923-73bf-8081-d0b1a8c5264d", "version": 1, "description": "Big-number or KPI value." }, "tool": { "name": "Quantification", "slug": "quantification", "status": "active", "bestFor": null, "canonId": "019dd9e1-47ab-72ce-a079-aab1f5299e88", "version": 1, "bodyDocId": null, "description": "Translating a claim into numbers, charts, or tables.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": "primary", "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:28+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9ccd-eed2d5fe154f", "parentComponentId": null }, { "bbox": { "h": 0.3, "w": 0.68, "x": 0.07, "y": 0.475 }, "kind": "paragraph", "text": "The top five important features extracted from the training set of hERG model included N16 (a positively charged nitrogen atom in a saturated ring, such as piperidine or piperazine), C3 (an aromatic carbon atom with no substitution and adjacent to two aromatic carbon atoms), H2 (a hydrogen bonded to an aromatic carbon), M13 (a number of aromatic rings), and S5 (sulfur in a ring bonded to two aromatic atoms). These features summarize the two key characters of the hERG blockers – an aromatic moiety and a positive charge center, which is in good agreement with commonly recognized pharmacophore models of hERG blockers.[3b] Compounds containing two N16 nitrogen atoms have a greater than 73% chance to block hERG channels, and the probability dropped sharply to 10% for compounds without an N16 atom (Figure 9a). Piperazine and piperidine are two moieties frequently used by medicinal chemists to manipulate molecular flexibility and hydrophobicity. However, both structure features have high potential to trigger undesirable hERG activity, unless the basicity of the ring nitrogen atoms is alleviated by introducing neighboring aromatic rings or carbonyl groups.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:48.203+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "242e7752-8f16-4296-b97b-88a648478020", "parentComponentId": null }, { "bbox": { "h": 0.34, "w": 0.925, "x": 0.07, "y": 0.068 }, "kind": "paragraph", "text": "The first paper – by NIH researchers - screened more than 4,000 drug molecules to determine which factors drive drug-induced hERG blockade and QT prolongation. Ominously for pitolisant, the top factor identified in the hERG model was a “nitrogen atom in a saturated ring, like piperidine....” The scientists then validated the model with drugs known to have hERG liability, and it accurately predicted the hERG liability of several histamine-receptor drugs that were recalled. 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Our investigation reveals Bioprojet’s multi-decade attempt to develop a histamine H3 receptor drug, resulting in one utter failure after another – including pitolisant.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:47.895+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "4145fa60-8371-450a-9870-38adc3a0ea83", "parentComponentId": null }, { "bbox": { "h": 0.18, "w": 0.86, "x": 0.07, "y": 0.22 }, "kind": "paragraph", "text": "From our review of every paper published by Jean-Charles Schwartz going back to the 1990's, we were startled to discover that pitolisant is an ancient compound, first synthesized a quarter-century ago. 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He stated that thioperamide was the first H3-receptor compound, developed in 1987, but it “displayed hepatoxicity.” Then Bioprojet developed ciproxifan “which had to be abandoned after toxicity tests performed by Bioprojet.” Tellingly, he stated that “drug companies remained essentially uninterested in this research.”", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:48.195+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "42e9fa45-59c6-4a82-920c-7a35e465bbd9", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "\"displayed hepatoxicity.\" — Jean-Charles Schwartz (2010 paper). \"which had to be abandoned after toxicity tests performed by Bioprojet.\" — Jean-Charles Schwartz (2010 paper). \"drug companies remained essentially uninterested in this research.\" — Jean-Charles Schwartz (2010 paper).", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:29+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9cce-6d1c431cbfae", "parentComponentId": null }, { "bbox": { "h": 0.02, "w": 0.4, "x": 0.07, "y": 0.95 }, "kind": "source-note", "text": "Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3111674/?report=classic", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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Compound FUB 637 (Fig. 4), a potent histamine H3 receptor antagonist tested in vitro (hKi: 3.1 nM) and in vivo (ED50: 3.7 ± 1.0), was taken as a lead structure.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:47.341+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "7714412a-2a6c-4575-9224-e1c1f05e0226", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "The present report provides an account of the synthesis and pharmacological evaluation of the new histamine H3 receptor ligands. 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JNJ-17216498 in Patients With Narcolepsy", "attrs": null, "canon": { "kind": { "name": "List", "slug": "list", "status": "active", "canonId": "019de52c-f94b-779b-a53b-fd4904a5f4d2", "version": 1, "description": "Bullet or numbered list." }, "tool": null, "subkind": { "name": "Bullet list", "slug": "bullet", "status": "active", "canonId": "019de52c-fc98-7169-a083-5cab805076ca", "version": 1, "description": null }, "framework": null }, "subkind": "bullet", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:52.219+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "305fb3f9-9584-402f-a182-f3ece372ac17", "parentComponentId": null }, { "bbox": { "h": 0.08, "w": 0.86, "x": 0.07, "y": 0.84 }, "kind": "list", "text": "Pfizer failed phase 2 trial for narcolepsy with EDS\nA Study Of A Novel Compound For Excessive Daytime Sleepiness Associated With Narcolepsy", "attrs": null, "canon": { 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a variety of off-target effects; and a broad toxicity profile.", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": { "name": "Visual emphasis", "slug": "visual-emphasis", "status": "active", "bestFor": null, "canonId": "019dd9e1-474b-736b-a8eb-a794dd88241c", "version": 1, "bodyDocId": null, "description": "Drawing the eye to one element above the rest of the slide.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:29+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9cce-83255f3a96e5", "parentComponentId": null }, { "bbox": { "h": 0.06, "w": 0.86, "x": 0.07, "y": 0.58 }, "kind": "paragraph", "text": "New developments around histamine H3 receptor antagonists/inverse agonists: a patent review (2010 – present)", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:52.469+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "479fdbca-b50b-4b54-9e01-9decbff49e80", "parentComponentId": null }, { "bbox": { "h": 0.25, "w": 0.86, "x": 0.07, "y": 0.66 }, "kind": "paragraph", "text": "Generally, H3R as a drug target is not easy. So far, > 20 years after identification of the receptor and >15 years after cloning it, non-of-ligand has entered into the market. The complicated pharmacology of H3R makes this way difficult. Differences in results and species dependency (with largest between bH3R and rH3R) have hindered interpretation of preclinical studies. 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2407, "nDataPoints": 0, "notes": "The slide uses a forensic literature review approach to highlight historical concerns about the drug's safety profile (cardiotoxicity, bioavailability, etc.) that were allegedly ignored or suppressed.", "elementsJson": [ "paragraph", "screenshot" ], "confidence": 1, "extraction": { "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "at": "2026-05-02 20:17:50.594+00", "seconds": 3.439, "promptVersion": "v2-canon-conditioned" } }, "links": { "slide": "/slides/019dd923-622c-750b-8b9a-21918ac10c17/79", "deck": "/decks/019dd923-622c-750b-8b9a-21918ac10c17", "deckAnchor": "/decks/019dd923-622c-750b-8b9a-21918ac10c17#slide-79", "deckJson": "/decks/019dd923-622c-750b-8b9a-21918ac10c17.json" }, "components": [ { "bbox": { "h": 0.05, "w": 0.86, "x": 0.07, "y": 0.58 }, "kind": "callout", "text": "2010 review paper on H3 receptor compound programs indicated threw cold water on pitolisant", "attrs": null, "canon": { "kind": { "name": 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and also had the potential for inducing phospholipidosis, possibly due to the high clogP (4.8) [76].", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": { "name": "Visual emphasis", "slug": "visual-emphasis", "status": "active", "bestFor": null, "canonId": "019dd9e1-474b-736b-a8eb-a794dd88241c", "version": 1, "bodyDocId": null, "description": "Drawing the eye to one element above the rest of the slide.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:29+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9ccf-50dc124a6c94", "parentComponentId": null }, { "bbox": { "h": 0.45, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "Although Harmony and Bioprojet claim pitolisant is effective and safe, our research uncovered devastating, long-buried evidence that other large pharma companies synthesized pitolisant and concluded that it is plagued by severe problems including cardiotoxicity - and that the claims in Bioprojet’s seminal paper could not be replicated in their labs or others. Although pitolisant was approved in the US in 2019, it is a quarter-century old compound - Bioprojet’s key papers were published in the mid-2000’s, and the trials upon which it received FDA approval are circa-2010. Most of the research in the space dates to the 1990’s and 2000’s, after which it fell off a cliff as pharma companies fled after widespread failures. As past of our forensic literature review, we first noted a few lines in a 2010 paper that indicated that “the development and druggability of tiprolisant (BF2.649)” has “been questioned, since it had limited oral bioavailability, was a potent inhibitor of CYP2D6 and hERG, and also had a high potential for inducing phospholipidosis....” – tiprolisant was an earlier name for pitolisant.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:50.594+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "6ff8bac9-8547-48d3-b2c5-dfd8a7696445", "parentComponentId": null }, { "bbox": { "h": 0.18, "w": 0.86, "x": 0.07, "y": 0.71 }, "kind": "paragraph", "text": "shorter brain residence time [44]. The development and druggability of tiprolisant (BF2.649 5), reportedly in Phase II clinical trials for a number of potential indications, including cognitive enhancement, have been questioned, since it had limited oral bioavailability, was a potent inhibitor of CYP2D6 and hERG, and also had the potential for inducing phospholipidosis, possibly due to the high clogP (4.8) [76].", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:50.594+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "78165a7b-3481-45a5-956f-147f057286a2", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "“the development and druggability of tiprolisant (BF2.649) has been questioned, since it had limited oral bioavailability, was a potent inhibitor of CYP2D6 and hERG, and also had a high potential for inducing phospholipidosis….” — 2010 review paper on H3 receptor compound programs", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:29+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9ccf-5414cd395893", "parentComponentId": null }, { "bbox": { "h": 0.03, "w": 0.25, "x": 0.07, "y": 0.92 }, "kind": "source-note", "text": "Source: https://pubmed.ncbi.nlm.nih.gov/20166960/", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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"extraction": { "at": "2026-04-22 23:49:29+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9cce-f5f1ef561cf5", "parentComponentId": null }, { "bbox": { "h": 0.45, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "The paper cited a 2008 publication by scientists at Abbott, which we located and is one of the most cited in the field – and we further spoke to a scientist who was closely involved in Abbott’s efforts, which we shall detail. The authors make it clear that they synthesized pitolisant in their lab, as the structure had already been published. Their comments are remarkable and indicated that pitolisant is a total failure on all dimensions: pharmacokinetics, efficacy, and safety. They state that the 84% oral bioavailability claims in Bioprojet’s key 2007 paper – absurdly, only based on an animal study – “were not replicated in our lab (with 30, 5, and 2% bioavailability in mice, rat, and dog).” They add that “this limited oral bioavailability questions the data related to the ability of BF2.639 to increased [sic] histamine brain levels after oral administration” as well as their claims in another key paper. They further indicate severe toxicity: “our laboratory findings suggest that CYP2D6 inhibition, potent hERG binding and the potential for phospholipidosis would likely be important hurdles.”", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:50.596+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "538c4443-f61a-45b8-8b09-e02247964c50", "parentComponentId": null }, { "bbox": { "h": 0.28, "w": 0.86, "x": 0.07, "y": 0.63 }, "kind": "paragraph", "text": "Pharmacokinetic parameters measured by a radioreceptor assay indicated that BF2.649 exhibits 84% oral bioavailability in mice. However, these data were not replicated in our lab (with 30, 5 and 2% bioavailability in mice, rat and dog). One recent report indicated a 2-h half-life and good brain penetration in mice using a superior analytical assay but no detailed pharmacokinetic parameters were provided (Ligneau et al., 2007a). This limited oral bioavailability questions the data related to the ability of BF2.649 to increased histamine brain levels after oral administration in mice and the EEG studies conducted in cats. Further studies these species. BF2.649 is presently under clinical investigation in several Phase II trials for the treatment of schizophrenia, ADHD, dementia and Parkinson’s disease. (www.stanleyresearch.org/programs/trialgrants.htm). From the development point of view, our laboratory findings suggest that CYP2D6 inhibition, potent hERG binding and the potential for phospholipidosis would likely be important hurdles for this novel compound.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:50.596+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "e1efe999-48b7-4926-9486-7e2abb320ea5", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "“were not replicated in our lab (with 30, 5, and 2% bioavailability in mice, rat, and dog).” — Abbott Researchers; “this limited oral bioavailability questions the data related to the ability of BF2.639 to increased [sic] histamine brain levels after oral administration” — Abbott Researchers; “our laboratory findings suggest that CYP2D6 inhibition, potent hERG binding and the potential for phospholipidosis would likely be important hurdles.” — Abbott Researchers", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:29+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9cce-fa3160a6d1c1", "parentComponentId": null }, { "bbox": { "h": 0.02, "w": 0.4, "x": 0.07, "y": 0.94 }, "kind": "source-note", "text": "Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2483387/pdf/bjp2008147a.pdf", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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Further in vitro profiling in our laboratory (and others [15]) suggests that BF2.649 has both a CYP 2D6 liability (IC50 = 0.4 µM) and potent hERG K+ channel blockade (IC50 = 0.49 µM). BF2.649 is also reported to have poor PK profiles in both rat and dog (5% and 2% bioavailability, respectively [15]). Despite these issues, BF2.649 has been extensively profiled in pre-clinical animal models [62] and progressed into the clinic. Bioprojet recently reported the first clinical evi-", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:51.19+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "1dfd2ebd-9299-411e-b50c-2019cd31bcec", "parentComponentId": null }, { "bbox": { "h": 0.25, "w": 0.85, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "Abbott’s comments were echoed in a 2009 paper by scientists at Evotec, a major drug development player that works with most of the world’s largest pharma companies. They indicated that they synthesized pitolisant in their laboratory, then known as BF2.649: “in vitro profiling in our laboratory (and others) suggests that BF2.649 has both a CYP 2D6 liability (IC50 = 0.4 mM) and potent hERG K+ channel blockade (IC50 = 0.49 mM).” They further indicated it has a poor pharmacokinetic profile with extremely low bioavailability.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:51.19+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "7f7843a0-ffce-4375-a2c0-e7a9635bb71b", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "in vitro profiling in our laboratory (and others) suggests that BF2.649 has both a CYP 2D6 liability (IC50 = 0.4 µM) and potent hERG K+ channel blockade (IC50 = 0.49 µM). — Evotec researchers (2009 paper)", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:29+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9ccf-0ccf4a7be182", "parentComponentId": null }, { "bbox": { "h": 0.02, "w": 0.25, "x": 0.07, "y": 0.95 }, "kind": "source-note", "text": "Source:https://pubmed.ncbi.nlm.nih.gov/19429511/", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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and which still failed.", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": { "name": "Visual emphasis", "slug": "visual-emphasis", "status": "active", "bestFor": null, "canonId": "019dd9e1-474b-736b-a8eb-a794dd88241c", "version": 1, "bodyDocId": null, "description": "Drawing the eye to one element above the rest of the slide.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:29+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9ccf-68d022a233d7", "parentComponentId": null }, { "bbox": { "h": 0.12, "w": 0.86, "x": 0.07, "y": 0.55 }, "kind": "paragraph", "text": "We begin with color by an ex-executive/senior scientist at Abbott, now at another major pharma company, who stated that they had an extensive H3 development program that \"never went anywhere\" - specifically for narcolepsy - despite their decades-long experience with histamine receptors given Abbott's H1 agonist drug betahistine.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:51.881+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "0edc75c4-f667-413e-aaf9-02cc7fb5f29c", "parentComponentId": null }, { "bbox": { "h": 0.18, "w": 0.86, "x": 0.07, "y": 0.19 }, "kind": "paragraph", "text": "In two cases, they appear to have independently synthesized and studied pitolisant as a comparator. 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All three were intimately familiar with pitolisant and criticized it for having the same fatal flaws, based on their analysis or testing, and characterized it as an old, simple, and inferior compound compared to the molecules they developed - and which still failed.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:51.881+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "9753eb08-0353-4f3f-b4f6-851bb39265fa", "parentComponentId": null }, { "bbox": { "h": 0.25, "w": 0.86, "x": 0.07, "y": 0.68 }, "kind": "quote", "text": "Abbott had an extensive H3 receptor program that \"never went anywhere\" - specifically for narcolepsy\nA: \"At Abbott, we had historically worked a lot on a histaminic receptor...\"\nQ: \"And did it ever go anywhere?\"\nA: \"No, it never went anywhere.\"", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": null, "subkind": { "name": "Testimonial", "slug": "testimonial", "status": "active", "canonId": "019de52c-fc21-71b6-9ac3-8266a64945e8", "version": 1, "description": null }, "framework": null }, "subkind": "testimonial", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:51.881+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "f163f94d-7bac-46a6-aa07-020d7307080b", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "\"No, it never went anywhere.\" — Senior pharmaceutical executive/scientist, previously at Abbott and now at another major pharma company", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:29+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9ccf-6d7963e0145d", "parentComponentId": null }, { "bbox": { "h": 0.03, "w": 0.3, "x": 0.07, "y": 0.95 }, "kind": "source-note", "text": "Source: Scorpion Capital consultation calls with experts", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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That's the enzyme that actually degrades it. 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And do you have enough concentration for the active metabolite to really saturate the receptor? Because the problem with H3 receptors is they are everywhere. The H3 receptor exists in many places. The most important one is the brain, but you need a certain level of saturation to really reach the point that you're going to see an effect, that this patient starts waking up again or keeping enough attention.”", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": null, "subkind": { "name": "Testimonial", "slug": "testimonial", "status": "active", "canonId": "019de52c-fc21-71b6-9ac3-8266a64945e8", "version": 1, "description": null }, "framework": null }, "subkind": "testimonial", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:52.299+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "eceb2c33-1e6d-4704-8dc3-5e7e3e4c51f1", "parentComponentId": null }, { "bbox": { "h": 0.05, "w": 0.86, "x": 0.07, "y": 0.86 }, "kind": "quote", "text": "A: “Yes. 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Narcolepsy is a huge need. Here is the problem. This product has a huge patient-to-patient variability in terms of how it's absorbed and how it actually passes the blood-brain barrier or moves past the blood-brain barrier. So, the biggest problem here is what we call the DDMPK, Drug Distribution and Metabolism, the mechanism of action. In a lab, it works wonderfully. In cells, it works, even in rat models, and we've even done models in dogs, and it works. The problem is in humans, the metabolism of such drug classes allows very high variability and very, very low bio-availability to reach even a 1% maximum. 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There are many why's. It's a kind of weird case but unfortunately, there was no good efficacy. And that was puzzling. When we attempted to increase the dose, there was some issues with the toxicity part.”\nQ: “What were the toxicity issues? And these are all animal studies? Are these are healthy volunteer studies?”\nA: “I'm talking to you about the animal studies and first time in humans and also phase 2 as well.\nQ: “So, there was toxicity—where did you guys observe the toxicity in the animal and volunteers in the phase 2 studies?”\nA: “Normally, we start with animals, as you probably know. And we do dose escalation in animals, so we did that, and it was fine up to the dose that we tried with animals. The first time in a human, as you probably know, they try a lower dose, which was fine. In the second study, phase 2, which again, this is toxicity but it's a larger population you do what's called dose escalation to try to see what's the tolerability of the subject in terms of dosing, and what dose they can tolerate. And yeah, there were some serious side effects when we tried to increase the dose.”\nQ: “Do you remember at what dose that happened?\nA: “We started from 25 mg, we tried 50 mg, 250 mg, 100 mg, something like that. That was one of the problems because it's working with cellular signaling.”\nQ: “This was the Alzheimer's trial, GSK239512?”\nA: “Yes, I think you are right.”\nQ: “I'm just looking it up online while we're talking. A 16-week, phase 2, multicenter, randomized, double-blind, placebo-controlled trial. Started November 2009. It was supposed to end a year later, in November 2010. Do you remember how many patients were enrolled?”\nA: “Yes, that was actually phase 2 was less than 100, I think there were 30. 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also off-target H4 receptor binding", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:00.15+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "65b79f8f-ba67-4471-9756-dd65f9db580e", "parentComponentId": null }, { "bbox": { "h": 0.25, "w": 0.86, "x": 0.07, "y": 0.68 }, "kind": "quote", "text": "“The point I’m making is they had great compounds for rats. I’d never seen data against the human receptor. They must have it somewhere. The other thing is some of those compounds, a year after [redacted] cloned the H3 receptor, he cloned the H4 receptor, so there’s a fourth histamine receptor. We characterized the histamine H4 receptor. And one of the first things we did was take all the H3 compounds that we had access to, to determine if they had an affinity for the H4 receptor. I’ve never seen that data for pitolisant. I think that’s less likely but for them to have H4 affinity, but I don’t know [..] The other thing is I’ve never seen data with respect to speciation. So, how does it perform against, say, a mouse, rat, dog, or human? And we wanted to show our compounds were super-specific, and we knew they had an affinity for H3 in the mouse, so what we did is we made a knockout mouse that had no H3 receptors, and we showed that our compounds didn’t bind anywhere in these animals where there were no H3 receptors. 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The reason we could move very, very fast is that we had the human cloned receptor. So, we could screen our compounds against the human receptor, whereas all the work done prior to that—and Abbott was quick to do this as well because they had actually cloned a receptor that mistakenly characterized it as a cholinergic receptor, not a histamine receptor [...] But when Jean-Charles Schwartz did this, it was old-school pharmacology with, I guess, it was rodent tissue strips or something. Or it was in some sort of tissue. So, they used rats. So, all their compounds that they found initially were good for rats. And then they kept advancing the compound, but, of course, they hadn’t got access to the human clone, so they didn’t know how good it was against the human receptor. There was a Wakix screen against the human receptor, but it was really, really complex. And I remember talking to Sir James Black, who had found the H2 antagonist years ago, about what tissue do you use in humans. 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And you're correct. There is this cardiovascular signal, which was known - I'm sure it was known as soon as people profiled it.” As additional evidence, he stated that Lilly also observed cardiotoxicity in their H3 clinical trials but that it is not public: “they observed some things in clinical trials. 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Let me just give you a piece of...that's not to say that other companies did look at pitolisant. And you're correct. There is this cardiovascular signal, which was known—I'm sure it was known as soon as people profiled it. 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And they said this was confirmed by another lab, and they referenced a verbal conversation. They didn't footnote it; it wasn't published. So, there are two citations that I've come across that are very brief and very vague that reference cardiotoxicity. And then there's actually a paper that the Bioprojet people put out where they propose this algorithmic method for identifying hERG toxicity based on whatever the molecular structure is. But I thought it was very interesting that the paper was in 2011 after they'd already done a lot of work on pitolisant, and they called it BF2-something or the other or tiprolisant at the time. 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In those days, there had been a lot of drugs withdrawn from the market because of what they call Torsades de Pointes...when that happens, it's pretty quick you're going to die shortly afterwards. So, there are a number of compounds. Astemizole and Seldane, the antihistamine, and there were many others. There was a compound from Pfizer as well. They all saw what's called QT prolongation, and then they were able to associate that with the hERG channel. So, everybody then becomes concerned about, well, we have to have a hERG-binding screen in our drug-drug discovery efforts because we don't really want to launch a compound with all these problems. In the intervening years, hERG is a component—and they have high throughput patch plant methods now—so, your hERG component, your measurement is important. But with the advances in sort of molecular biology, you can now use cardiomyocytes, beating cardiomyocytes. And so, those assays have become just as important. So, hERG is now just one component of cardiovascular safety. What a company—and what I would do in my laboratory—we would have much more sophisticated cardiovascular safety. I would be surprised, based on what I've heard about pitolisant, if it would get a passing grade in what we would do, say, in 2022. So, there were a whole lot of changes happening between 2002 and now to make sure that the cardiovascular risk of your compounds is minimal or at least it's manageable.” -Ex-longtime senior scientist at Johnson & Johnson, with global leadership roles in neuroscience", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:57.285+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "343515d6-ff3b-4776-bab5-88d07e020c24", "parentComponentId": null }, { "bbox": { "h": 0.25, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "He hinted - in our opinion - that J&J could easily have licensed pitolisant if Bioprojet’s claims were true but ran for the hills: “if we had been super, super interested, we could have done it...but we weren't because we felt we had much better compounds - we knew we had better compounds”; “if we felt that was the bee’s knees....” He also expressed skepticism of pitolisant’s published hERG/cardiac safety study, calling the methodology old-school and primitive, and stated that he “would be surprised” if pitolisant “would get a passing grade” now on cardiovascular safety.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:57.285+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "8bc0c6fe-9751-4753-8042-74e70ca4e915", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "“To be honest, the fact that I can tell you—I can only tell you what I've seen [in public] at meetings. 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So, if an H3 antagonist works with Prader-Willi, then there are better compounds out there that are probably safer.", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": { "name": "Visual emphasis", "slug": "visual-emphasis", "status": "active", "bestFor": null, "canonId": "019dd9e1-474b-736b-a8eb-a794dd88241c", "version": 1, "bodyDocId": null, "description": "Drawing the eye to one element above the rest of the slide.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:31+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9cd1-4756c4cb2042", "parentComponentId": null }, { "bbox": { "h": 0.25, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "He expressed other criticism of pitolisant, stating that the compound was so old – dating back perhaps to 1999 or earlier – that it couldn’t have any intellectual property left. In addition, he was familiar with Harmony’s recent phase 2 data for sleepiness in Prader-Willi syndrome, and indicated it was anecdotal and lacked credibility: “there are far better H3 antagonists out there if this works. So, if an H3 antagonist works with Prader-Willi, then there are better compounds out there that are probably safer. I got the impression, too, a lot of pharmaceutical companies thought H3 was a target in search of a disease.”", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:55.098+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "fe618a4c-2874-479d-a6ef-6c75467ee1f6", "parentComponentId": null }, { "bbox": { "h": 0.25, "w": 0.86, "x": 0.07, "y": 0.67 }, "kind": "quote", "text": "“I've seen clinical trial results geography-dependent. I did a meeting in Poland last month where I saw a presentation on Wakix. And Wakix has been picked up by—is being used by a charitable group in the United States that are focused on Prader-Willi Syndrome. My recollection, though, is that it was anecdotal data. They spoke to the patients, and I saw some videos of the patients, and they seemed better. But it was all anecdotal. I don't think—I'm not sure the patient population is big enough for it to demonstrate a statistical significance, actually. But that's where they're going, and they got this charitable foundation, I think, to work with them. And I remember saying to the guy that presented, I said there are far better H3 antagonists out there if this works. So, if an H3 antagonist works with Prader-Willi, then there are better compounds out there that are probably safer. I got the impression, too, a lot of pharmaceutical companies thought H3 was a target in search of a disease.” –Longtime senior scientist at Johnson & Johnson, with global leadership roles in neuroscience", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": null, "subkind": { "name": "Testimonial", "slug": "testimonial", "status": "active", "canonId": "019de52c-fc21-71b6-9ac3-8266a64945e8", "version": 1, "description": null }, "framework": null }, "subkind": "testimonial", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:55.098+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "7646ce0e-d0bb-4511-9a37-b9f5e4ee9caf", "parentComponentId": null }, { "bbox": { "h": 0.18, "w": 0.86, "x": 0.07, "y": 0.41 }, "kind": "quote", "text": "A: “The other thing about that compound is I don't know how strong the intellectual property is. I'm assuming you've looked at that.” Q: “It's one of the things I need to get to. But the thing is so old.” A: “It's got to be. My recollection is I saw applications from Jean-Charles Schwartz, from Walter Schnunack, and all these old guys—Walter is actually dead now—they had huge patent applications that they filed. But I don't know—I'm not an attorney. I think that compound was out there in 1999. So, that's a long time ago. 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The plasma level average was 100.6±78.1 ng/ml (n=17). Elevated plasma levels (> 150 ng/ml) were observed in 5 patients, in some cases related to the experience of adverse events occurring a few hours after drug intake.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:54.9+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "9471dd31-20a6-4262-a1bf-cb3280b2ed70", "parentComponentId": null }, { "bbox": { "h": 0.35, "w": 0.85, "x": 0.07, "y": 0.13 }, "kind": "paragraph", "text": "The first patient data was published in 2007, when the drug was still known as tiprolisant. 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Yet the paper is written to convey the impression that the average plasma level and range is far lower: “the plasma level average 100.6 + 78.1 ng/mL (n=17).” But note the insertion of “n=17” – in other words, the study had 22 patients, but Bioprojet EXCLUDED the five with plasma levels >150 ng/mL in the calculation, making it impossible to deduce how high it went. 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Tellingly, the distribution of severe adverse events listed in the relevant paragraph doesn’t mention fainting at all, but includes a vague category called “malaise sensation (n=2)” which we presume is an attempt to downplay the fainting – as fainting sensation (known as syncope) is well-established as the most common symptom of QT prolongation. Two patients with fainting across 22 total suggests an extreme cardiotoxicity signal.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:55.748+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "5a9e3925-1af6-42e2-974d-0563ea117562", "parentComponentId": null }, { "bbox": { "h": 0.35, "w": 0.86, "x": 0.07, "y": 0.56 }, "kind": "paragraph", "text": "first 3 days of treatment. Seven adverse events rated severe occurred in 6 patients during tiprolisant period (and two under the placebo period), six of them likely or very likely related to the tiprolisant treatment, i.e. insomnia (n=2), malaise sensation (n=2), nausea (n=1) and hallucination (n=1). None of these adverse events led to treatment cessation and 21/22 patients fully complied with the prescribed treatments. However, one patient reduced the dosage of tiprolisant from 40 mg/day to 10 mg/day because of adverse events such as mild auditory hallucinations without hypnagogic or hypnopompic characteristics, insomnia and malaise, which then disappeared with the dose reduction and another patient stopped the treatment the day before the exit visit with the investigator. Finally, there were no differences among placebo and period (31.8%). The most frequent adverse events were headache, nausea, insomnia, experienced mainly during the first 3 days of treatment. 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"/decks/019dd923-622c-750b-8b9a-21918ac10c17#slide-111", "deckJson": "/decks/019dd923-622c-750b-8b9a-21918ac10c17.json" }, "components": [ { "bbox": { "h": 0.07, "w": 0.75, "x": 0.07, "y": 0.52 }, "kind": "callout", "text": "Only a single sentence on cardiovascular safety in the papers for the pivotal phase 3 narcolepsy trials, with no data shown", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": null, "subkind": { "name": "Primary callout", "slug": "primary", "status": "active", "canonId": "019de52c-fbd1-70eb-a9ce-8997f8674c1d", "version": 1, "description": null }, "framework": null }, "subkind": "primary", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:56.06+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": 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Blood chemistry and haematological or cardiovascular parameters did not change in either group.", "attrs": null, "canon": { "kind": { "name": "List", "slug": "list", "status": "active", "canonId": "019de52c-f94b-779b-a53b-fd4904a5f4d2", "version": 1, "description": "Bullet or numbered list." }, "tool": null, "subkind": { "name": "Bullet list", "slug": "bullet", "status": "active", "canonId": "019de52c-fc98-7169-a083-5cab805076ca", "version": 1, "description": null }, "framework": null }, "subkind": "bullet", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:56.06+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "4129605a-c0d8-42d7-9f98-adcd5b8b0230", "parentComponentId": null }, { "bbox": { "h": 0.2, "w": 0.42, "x": 0.07, "y": 0.6 }, "kind": "list", "text": "Harmony 1: Pitolisant versus placebo or modafinil in patients with narcolepsy: a double-blind, randomised trial. three patients in the modafinil group. Blood chemistry tests or cardiovascular parameters did not change in the three study group (data not shown).", "attrs": null, "canon": { "kind": { "name": "List", "slug": "list", "status": "active", "canonId": "019de52c-f94b-779b-a53b-fd4904a5f4d2", "version": 1, "description": "Bullet or numbered list." }, "tool": null, "subkind": { "name": "Bullet list", "slug": "bullet", "status": "active", "canonId": "019de52c-fc98-7169-a083-5cab805076ca", "version": 1, "description": null }, "framework": null }, "subkind": "bullet", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:56.06+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "d9473846-b8db-4a62-82c4-b8f3818f2f07", "parentComponentId": null }, { "bbox": { "h": 0.45, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "Not surprisingly, Bioprojet’s narcolepsy studies fail to disclose cardiovascular safety data. Given that their preclinical papers, such as the in vitro hERG and Purkinje fibre study, asserted zero risk, the failure to showcase this safety profile with clinical data is damning. The Harmony 1 pivotal trial didn’t even conduct ECG’s on treatment groups – just a baseline ECG, presumably to cherry-pick and screen out patients with cardiac issues. The Harmony 1 paper states that “blood chemistry tests or hematological or cardiovascular parameters did not change in the three study groups (data not shown).” The Harmony CTP trial conducted ECG’s at each visit, yet once again no data or discussion is included other than the same sentence above from Harmony 1. The Harmony 3 paper states that ECG’s were conducted at baseline and at 6 and 12 months of dosing, but once again the data is missing and we are left with a single sentence asserting safety.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:56.06+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "ab07dbdb-99b4-4715-8648-30efd4dd6126", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "Blood chemistry tests or hematological or cardiovascular parameters did not change in the three study groups (data not shown). — Harmony 1 paper", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:31+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9cd1-327166e4d9c5", "parentComponentId": null }, { "bbox": { "h": 0.03, "w": 0.75, "x": 0.07, "y": 0.95 }, "kind": "source-note", "text": "Source: https://pubmed.ncbi.nlm.nih.gov/24107292/; https://pubmed.ncbi.nlm.nih.gov/28129985/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6802569/pdf/zsz174.pdf", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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The primary end point was change in the Epworth Sleepiness Scale (ESS) score in the intention-to-treat population. Key secondary end points were maintenance of wakefulness assessed by the Oxford Sleep Resistance Test, Clinical Global Impressions scale of severity, the patient’s global opinion, EuroQoL quality-of-life questionnaire score, Pichot fatigue questionnaire score, and safety.\nRESULTS: Two hundred forty-four OSA participants (82.8% men; mean age, 53.1 years; mean Apnea Hypopnea Index with CPAP, 4.2/h; baseline ESS score, 14.7) were randomized to pitolisant (n = 183) or placebo (n = 61). ESS significantly decreased with pitolisant compared with placebo (-2.6; 95% CI, -3.9 to -1.4; P < .001), and the rate of responders to", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:00.725+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "cd9f8147-4cc2-468a-b0ee-d8c16cff40b1", "parentComponentId": null }, { "bbox": { "h": 0.03, "w": 0.45, "x": 0.07, "y": 0.94 }, "kind": "source-note", "text": "Source: https://journal.chestnet.org/action/showPdf?pii=S0012-3692%2820%2935105-9", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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The trials indicate a troubling QTc prolongation signal as well as fatalities. We emphasize that this is in spite of 1) using only a 20 mg dose – half the max dose on the pitolisant label; and 2) once again excluding patients with cardiovascular issues – indicating the significant real-world danger when the dose is doubled and patients are not cherry-picked. 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However, in the pitolisant group, four participants (2.2%) demonstrated at least one postdose QT interval (using Fredericia's correction) (QTcF) of > 450 msec and six patients (3.3%) demonstrated one QTcF elongation of ≥ 60 msec, whereas two participants (3.3%) demonstrated QTcF of > 450 msec and three participants (4.9%) demonstrated QTcF elongation of ≥ 60 msec in the placebo group.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:56.026+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "ab0d14c6-02f2-44b7-bf43-4c656fbf7ac9", "parentComponentId": null }, { "bbox": { "h": 0.45, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "The abstract for HAROSA 1 claims that “no cardiovascular or other significant safety concerns were reported.” However, the results section states that four patients in the pitolisant group (n=183) exhibited “at least one postdose QT interval” of >450 msec and that six patients “demonstrated one QTcF elongation of ≥60 msec.” The paper then downplays the issue by stating that two patients in the placebo group (n=61) also had a QT interval >450 msec and that three had an elongation ≥60 msec – which we find odd given the cardiovascular exclusion criteria. Several omissions suggest that the placebo comparison is a contrived attempt to muddy the waters. First, it says “>450 msec” and “≥ 60 msec” without providing the range or individual values – a classic case of “How To Lie With Statistics.” Did the pitolisant QT intervals spike far higher than with placebo? Second, how many postdose QT intervals >450 msec did the four patients exhibit? 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the death (heart attack) and QTc changes were not likely related to study drug but no explanation is provided for this assessment – and we emphasize that patients with significant cardiovascular disease were excluded from the study.", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": { "name": "Visual emphasis", "slug": "visual-emphasis", "status": "active", "bestFor": null, "canonId": "019dd9e1-474b-736b-a8eb-a794dd88241c", "version": 1, "bodyDocId": null, "description": "Drawing the eye to one element above the rest of the slide.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:32+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": 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Accordingly, results reported with pitolisant in the previous randomized controlled trials in patients with narcolepsy (14, 15) did not show any significant increase in QTc. A recent 1-year open-label", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:57.616+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "bd9e9c86-1846-4921-8683-75b4ab669d50", "parentComponentId": null }, { "bbox": { "h": 0.25, "w": 0.25, "x": 0.37, "y": 0.65 }, "kind": "paragraph", "text": "Our results confirm the favorable safety profile of pitolisant already reported in patients with narcolepsy (14, 15). No key changes were found in physical examination parameters or vital signs, depressive symptoms, and ECG or laboratory test results during the study. The changes reported in QTc (QTcF, >450 ms and elongation >60 ms) did not differ significantly between pitolisant and placebo. 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The CDER Clinical Pharmacology Review states the steady-state level is based on an undisclosed “Harmony model” – a black box.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:56.115+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "3307d31e-7da1-4acd-9f53-adf483a01e57", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "there was a clear and direct correlation of pitolisant exposure with QTc prolongation and that “at supratherapeutic doses, QTc increases greater than 10 msec are anticipated.” — FDA clinical review", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:33+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9cd2-9a25aeac114e", "parentComponentId": null }, { "bbox": { "h": 0.03, "w": 0.5, "x": 0.07, "y": 0.94 }, "kind": "source-note", "text": "Source: https://www.accessdata.fda.gov/drugs... | https://www.wakix.com/assets/pdf/WAKIX_pitolisant_tablets_PI_Dec_2022.pdf", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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The exposures in CYP2D6 PMs were approximately 2-fold higher.", "attrs": null, "canon": { "kind": { "name": "Table", "slug": "table", "status": "active", "canonId": "019de52c-f9c8-7148-8119-eaac9594cd28", "version": 1, "description": "Tabular data layout." }, "tool": null, "subkind": { "name": "Data table", "slug": "data", "status": "active", "canonId": "019de52d-02d5-75b8-8abf-88e92bf63569", "version": 1, "description": null }, "framework": null }, "subkind": "data", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:56.115+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "b90310dc-7a2a-476a-bda9-b7fb8139d587", "parentComponentId": null }, { "bbox": { "h": 0.15, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "title", "text": "We believe Harmony and Bioprojet have engaged in a systematic effort to conceal and under-estimate pitolisant’s plasma levels, which the evidence 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"page": 119, "type": "tension", "title": "The slide uses direct quotes from the EMA's CHMP assessment report to highlight regulatory discrepancies.", "function": "expose_contradiction", "rawType": "expose_contradiction", "block": null, "metadata": { "slideType": "expose_contradiction", "slideTypeCanon": { "name": "Expose contradiction", "slug": "expose_contradiction", "status": "active", "canonId": "019de52d-124c-75aa-984a-0a3d0d8fc8df", "version": 1, "description": null }, "function": "expose_contradiction", "functionCanon": { "name": "Expose contradiction", "slug": "expose_contradiction", "status": "active", "canonId": "019de52d-171f-776f-887c-73edaff4cf9c", "version": 1, "description": null }, "density": "dense", "densityScore": 53, "componentCount": 6, "textChars": 2560, "nDataPoints": 0, "notes": "The slide uses direct quotes from the EMA's CHMP assessment report to highlight regulatory discrepancies.", "elementsJson": [ "paragraph", "quote_block", "footnote" ], "confidence": 1, "extraction": { "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "at": "2026-05-02 20:18:01.562+00", "seconds": 7.119, "promptVersion": "v2-canon-conditioned" } }, "links": { "slide": "/slides/019dd923-622c-750b-8b9a-21918ac10c17/119", "deck": "/decks/019dd923-622c-750b-8b9a-21918ac10c17", "deckAnchor": "/decks/019dd923-622c-750b-8b9a-21918ac10c17#slide-119", "deckJson": "/decks/019dd923-622c-750b-8b9a-21918ac10c17.json" }, "components": [ { "bbox": null, "kind": "callout", "text": "The CHMP identified several shortcomings in the documentation provided on the pharmacokinetics of pitolisant.", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": { "name": "Visual emphasis", "slug": "visual-emphasis", "status": "active", "bestFor": null, "canonId": "019dd9e1-474b-736b-a8eb-a794dd88241c", "version": 1, "bodyDocId": null, "description": "Drawing the eye to one element above the rest of the slide.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:32+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9cd2-7ce405570192", "parentComponentId": null }, { "bbox": { "h": 0.38, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "The FDA's various pre-approval reviews indicate the agency simply accepted the company's PK claims at face value, despite striking red flags that we shall detail. However, the European Medicines Agency, as part of their review in 2015, exhibited significant concern, noting “shortcomings in the documentation provided on the pharmacokinetics of pitolisant”; “many discrepancies”; “gaps in the understanding of the pharmacokinetics of the drug, introducing uncertainty...in the safety and efficacy...when administered to different subgroups or when co-administered” – “despite further analysis” requested by the EMA; and that PK in elderly patients or those with “renal and hepatic impairment could not be safely predicted.” The EMA therefore requested various PK studies as post-approval measures. We find one sentence particularly striking – that the “gaps include basic pharmacokinetic properties of pitolisant.”", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:01.562+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "8bd5b6f5-0695-4bd2-862c-878397582269", "parentComponentId": null }, { "bbox": { "h": 0.35, "w": 0.86, "x": 0.07, "y": 0.56 }, "kind": "paragraph", "text": "The CHMP identified several shortcomings in the documentation provided on the pharmacokinetics of pitolisant. There were many discrepancies between the values of PK parameters in the different studies reports. Despite further analysis of the available data provided by the Applicant, there still are gaps in the understanding of the pharmacokinetics of the drug, introducing uncertainty in the assessment of the safety and efficacy of the product when administered to different subgroups or when co-administered with other drugs. These gaps include basic pharmacokinetic properties of pitolisant. Major elimination pathways are insufficiently understood for the drug and require additional investigations. Therefore, the Applicant has been requested to perform a new balance study after repeated dose administration in order to identify the major metabolites and characterize their PK behaviour and the mechanisms underlying their formation. This study will be conducted as a post-approval measure.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:01.562+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "b45c86a7-b165-435e-85c2-bd2e280bb7c6", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "“shortcomings in the documentation provided on the pharmacokinetics of pitolisant”; “many discrepancies”; “gaps in the understanding of the pharmacokinetics of the drug, introducing uncertainty...in the safety and efficacy...when administered to different subgroups or when co-administered” — EMA’s Committee for Medicinal Products for Human Use (CHMP)", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:32+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9cd2-8147d4ff64cb", "parentComponentId": null }, { "bbox": { "h": 0.02, "w": 0.55, "x": 0.07, "y": 0.94 }, "kind": "source-note", "text": "Source: https://www.ema.europa.eu/en/documents/assessment-report/wakix-epar-public-assessment-report_en.pdf", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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Data this basic is only withheld if it is damning. There is zero chance, in our opinion, that Bioprojet and/or Harmony are not in possession of this PK information. It is always collected, particularly given Bioprojet’s prolific papers and trials over a multi-decade effort to conjure up a successful H3R drug. As part of our investigation, we engaged a consultant who specializes in pharmacokinetic analysis, who echoed the EMA’s comments and expressed shock at the lack of basic PK data across pitolisant papers and studies. The consultant stated that this was the first time in decades she could not locate published plasma concentration curves for an approved drug, even from animal studies much less humans: “I don’t know how Harmony got away with this, honestly”; “the lack of data in this regard is a huge red flag given that 2D6 is the primary p450 involved in the elimination of pitolisant”; “it is hard to believe it was approved without it.”", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:57.796+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "56a150a9-3ad6-422a-99b3-3a1b64fef100", "parentComponentId": null }, { "bbox": { "h": 0.35, "w": 0.86, "x": 0.07, "y": 0.58 }, "kind": "quote", "text": "PK expert we engaged expressed shock at lack of pharmacokinetic data for pitolisant\n“There are no plasma concentration curves to actually compare it meaningfully to preclinical data. I have never seen this before when researching any approved clinical agent. One can find bazillions of plasma curves. Why did they not measure plasma levels in their trials - say 1 week after stable dose initiation at Tmax/3 hr when steady state? Why are there no published PK curves even for the animal studies? Especially with the weird subjective stable dose selection criteria used routinely in these trials and now in patients? We don’t know what the peak plasma levels are and I do not take anybody’s word - show me the data. They say 75 ng/mL is the max level like that is a stable number - it is not. The lack of data in this regard is a huge red flag given that 2D6 is the primary p450 involved in the elimination of pitolisant – it’s hard to believe it was approved without this.”", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": null, "subkind": { "name": "Testimonial", "slug": "testimonial", "status": "active", "canonId": "019de52c-fc21-71b6-9ac3-8266a64945e8", "version": 1, "description": null }, "framework": null }, "subkind": "testimonial", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:57.796+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "9607d0c3-93e4-472c-b6f8-1e7abc7a9257", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "“There are no plasma concentration curves to actually compare it meaningfully to preclinical data. I have never seen this before when researching any approved clinical agent... the lack of data in this regard is a huge red flag given that 2D6 is the primary p450 involved in the elimination of pitolisant – it’s hard to believe it was approved without this.” — Pharmacokinetic expert engaged by Scorpion Capital", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:33+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9cd2-de9804834770", "parentComponentId": null }, { "bbox": { "h": 0.02, "w": 0.3, "x": 0.07, "y": 0.94 }, "kind": "source-note", "text": "Source: Pharmacokinetic analysis commissioned by Scorpion Capital", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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I don't know how they got away with this honestly...", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": null, "subkind": { "name": "Pull quote", "slug": "pull-quote", "status": "active", "canonId": "019de52c-fbf9-76fe-97e1-a0b7540445c9", "version": 1, "description": null }, "framework": null }, "subkind": "pull-quote", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:57.375+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "91a1a85e-3732-446c-ad68-c4875cbd4f22", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "“So all of these careful and rather elegant in vitro/ex vivo and animal model studies for hERG are quite meaningless without key peak and AUC information across patients. 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20:17:59.154+00", "seconds": 4.367, "promptVersion": "v2-canon-conditioned" } }, "links": { "slide": "/slides/019dd923-622c-750b-8b9a-21918ac10c17/122", "deck": "/decks/019dd923-622c-750b-8b9a-21918ac10c17", "deckAnchor": "/decks/019dd923-622c-750b-8b9a-21918ac10c17#slide-122", "deckJson": "/decks/019dd923-622c-750b-8b9a-21918ac10c17.json" }, "components": [ { "bbox": { "h": 0.05, "w": 0.86, "x": 0.07, "y": 0.45 }, "kind": "callout", "text": "Pitolisant label indicates steady state Cmax 78 ng/mL (“range 49.2 ng/mL to 126 ng/mL”).", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": null, "subkind": { "name": "Primary callout", "slug": "primary", "status": "active", "canonId": "019de52c-fbd1-70eb-a9ce-8997f8674c1d", "version": 1, "description": null }, "framework": null }, "subkind": "primary", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:59.154+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "31b47d35-0b5d-4a4f-afdd-1e8b87b29d8e", "parentComponentId": null }, { "bbox": { "h": 0.08, "w": 0.86, "x": 0.07, "y": 0.67 }, "kind": "callout", "text": "2007 pilot study indicates 101 ng/mL with more variability, as well as a significant percentage of patients with levels elevated >150 ng/mL, who were excluded in calculating the average", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": null, "subkind": { "name": "Primary callout", "slug": "primary", "status": "active", "canonId": "019de52c-fbd1-70eb-a9ce-8997f8674c1d", "version": 1, "description": null }, "framework": null }, "subkind": "primary", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:59.154+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "bccc1b84-99e3-468e-abeb-22817d4c4088", "parentComponentId": null }, { "bbox": null, "kind": "callout", "text": "This clearly indicates that plasma levels are significantly higher than the range indicated on the label, and that the label is a fiction.", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": { "name": "Visual emphasis", "slug": "visual-emphasis", "status": "active", "bestFor": null, "canonId": "019dd9e1-474b-736b-a8eb-a794dd88241c", "version": 1, "bodyDocId": null, "description": "Drawing the eye to one element above the rest of the slide.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:32+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9cd2-654fa3150e1c", "parentComponentId": null }, { "bbox": { "h": 0.15, "w": 0.86, "x": 0.07, "y": 0.49 }, "kind": "paragraph", "text": "12.3 Pharmacokinetics Following oral administration of pitolisant 35.6 mg once daily, the steady state Cmax and AUC are 73 ng/mL (range: 49.2 to 126 ng/mL) and 812 ng*hr/mL (range: 518 to 1468 ng*hr/mL), respectively. Pitolisant exposure (Cmax and AUC) increases proportionally with dose and steady state is reached by day 7.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:59.154+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "8877c566-485e-44e6-aaef-395a81e6fedb", "parentComponentId": null }, { "bbox": { "h": 0.15, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "Given the lack of typical PK data, the asserted plasma levels are suspicious and exhibit various red flags. For example, the label states that at the max dose of 35.6 mg/day, the mean plasma is 73 ng/mL with a range between 42.9 ng/mL and 126 ng/mL.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:59.154+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "a261d1c1-d3f5-4116-9362-c57607706b10", "parentComponentId": null }, { "bbox": { "h": 0.15, "w": 0.86, "x": 0.07, "y": 0.75 }, "kind": "paragraph", "text": "Tiprolisant dosages were performed at the end of the treatment period with a median sampling time at 3.75 h after the last drug intake. The plasma level average was 100.6±78.1 ng/ml (n=17). Elevated plasma levels (> 150 ng/ml) were observed in 5 patients, in some cases related to the experience of adverse events occurring a few hours after drug intake.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:59.154+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "b48507f3-d4e4-43b3-b84e-7849763f8303", "parentComponentId": null }, { "bbox": { "h": 0.25, "w": 0.86, "x": 0.07, "y": 0.22 }, "kind": "paragraph", "text": "However, the 2007 pilot study indicated it was 101 ng/mL with a standard deviation of 78 ng/mL – 38% higher with a wider rage, despite the dose (40mg) being only 12% higher. Moreover, this pilot indicated 5 of 22 patients had far higher levels “> 150 ng/mL” – and as we noted earlier, the paper cleverly excluded those 5 in calculating the average of 101 ng/mL. This clearly indicates that plasma levels are significantly higher than the range indicated on the label, and that the label is a fiction.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:59.154+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "c32a393e-6017-4d0b-b8ba-b58431b5e031", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "Elevated plasma levels (> 150 ng/ml) were observed in 5 patients, in some cases related to the experience of adverse events occurring a few hours after drug intake. — 2007 pilot study", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:32+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9cd2-6b48776ae3f6", "parentComponentId": null }, { "bbox": { "h": 0.03, "w": 0.7, "x": 0.07, "y": 0.94 }, "kind": "source-note", "text": "Source: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211150Orig1s000ClinPharmR.pdf; https://pubmed.ncbi.nlm.nih.gov/18295497/", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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Neither study appears to be published, but we located a 2015 paper that excerpted some data from each.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:58.055+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "7f4288ea-413d-44c5-bb2f-ad57d3498587", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "Can an early phase clinical pharmacology study replace a thorough QT study? 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At steady state concentrations with the 40 mg dose, the expected mean (90% CI) increase in QTc is 4.2 (3.2 to 5.2) msec [...] The highest dose tested (240 mg) provides a 1.8-fold exposure margin over the high clinical exposure scenario and the expected mean increase is 15.5 (12.0 o 18.9) msec.”", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:59.671+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "7ba91cee-9eaa-4d38-bc75-d0050fd53755", "parentComponentId": null }, { "bbox": { "h": 0.15, "w": 0.86, "x": 0.07, "y": 0.51 }, "kind": "paragraph", "text": "The Sponsor evaluated the effect of pitolisant on the QT interval in two studies (Studies P09-11 and P14-05) [...] Study P09-11 was a total QT (TQT) study that evaluated doses up to 120 mg (single dose). Study P14-05 was a single ascending dose (SAD) study that evaluated doses up to 240 mg. 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The FDA noted that 107 mg was associated with a QT prolongation of 10 msec, the typical threshold beyond which a drug is considered cardiotoxic enough to prevent approval; and that 240 mg resulted in prolongation of 12-19 msec – “Most patients who receive pitolisant are unlikely to reach exposures seen with the 106.8 mg dose, as the highest recommended dose is 35.6 mg once daily.” The agency also noted the risk of higher blood concentration of pitolisant in patients with moderate liver or kidney issues, or poor CYP3D6 metabolizers.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:59.671+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "c777231e-037d-4127-bf32-a6a0328b3fa6", "parentComponentId": null }, { "bbox": { "h": 0.08, "w": 0.86, "x": 0.07, "y": 0.82 }, "kind": "paragraph", "text": "“At the recommended doses, pitolisant does not prolong the QT interval. 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"kind": "callout", "text": "The problem is that these supra-therapeutic doses were only SINGLE-DOSE and would not cover the steady-state peak plasma concentrations which are 2.3 times higher what they would be after a single dose, given pitolisant’s half-life and the implied accumulation ratio.", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": { "name": "Visual emphasis", "slug": "visual-emphasis", "status": "active", "bestFor": null, "canonId": "019dd9e1-474b-736b-a8eb-a794dd88241c", "version": 1, "bodyDocId": null, "description": "Drawing the eye to one element above the rest of the slide.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:34+00", "model": "unknown-legacy", "runId": null, "seconds": null, 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The TQT study (40- and 120-mg single doses) was conducted during March–August 2010 whereas the high-dose SAD study (160-, 200-, and 240-mg single doses) was conducted during October–November 2014 in order to extend even higher the dose range investigated in the TQT study.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:00.183+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "7c364dbb-9bfd-46d1-9f38-3759f860128c", "parentComponentId": null }, { "bbox": { "h": 0.35, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "The FDA’s interpretation of Harmony’s QT data is deeply flawed. First, although it clearly states that there is a dose-dependent QT prolongation, it incorrectly assumes that the 35.6 mg dose is below the threshold at which it manifests. The FDA simply assumes that Harmony’s assertion of average plasma levels at 35.6 mg (73 ng/mL) is correct, despite clear red flags indicating it is far higher. Second, the FDA’s entire analysis depends on the safety margins in the two cardiac safety studies (P09-11 and P14-05), which measured QT prolongation at supra-therapeutic doses of 120 to 240 mg. The problem is that these supra-therapeutic doses were only SINGLE-DOSE and would not cover the steady-state peak plasma concentrations which are 2.3 times higher what they would be after a single dose, given pitolisant’s half-life and the implied accumulation ratio.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:00.183+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "aaa4f270-6b39-40ea-9cb7-8114edc5c416", "parentComponentId": null }, { "bbox": { "h": 0.15, "w": 0.86, "x": 0.07, "y": 0.48 }, "kind": "quote", "text": "The Sponsor evaluated the effect of pitolisant on the QT interval in two studies (Studies P09-11 and P14-05) [...] Study P09-11 was a total QT (TQT) study that evaluated doses up to 120 mg (single dose). Study P14-05 was a single ascending dose (SAD) study that evaluated doses up to 240 mg. The TQT study did not find a clinically significant QTc prolonging effect with the recommended pitolisant dose of 40 mg once daily, though a dose of 120 mg was associated with QTc prolongation of approximately 10 milliseconds (msec).", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": null, "subkind": { "name": "Pull quote", "slug": "pull-quote", "status": "active", "canonId": "019de52c-fbf9-76fe-97e1-a0b7540445c9", "version": 1, "description": null }, "framework": null }, "subkind": "pull-quote", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:00.183+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "1d2c009c-a7f5-4f8c-8abb-55b6a8823f96", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "“The Sponsor evaluated the effect of pitolisant on the QT interval in two studies (Studies P09-11 and P14-05) [...] Study P09-11 was a total QT (TQT) study that evaluated doses up to 120 mg (single dose). 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"Comments by a pharmacology consultant engaged by Scorpion Capital", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": null, "subkind": { "name": "Primary callout", "slug": "primary", "status": "active", "canonId": "019de52c-fbd1-70eb-a9ce-8997f8674c1d", "version": 1, "description": null }, "framework": null }, "subkind": "primary", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:59.493+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "89499ad2-6c8f-46ec-848f-329fd403f428", "parentComponentId": null }, { "bbox": null, "kind": "callout", "text": "the peak plasma levels of Pitolisant after 6 consecutive daily doses will be 2.3x higher than they were on Day 1 but the Day 1 plasma concentrations were used to estimate the safety margins for QTcF.", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": { "name": "Visual emphasis", "slug": "visual-emphasis", "status": "active", "bestFor": null, "canonId": "019dd9e1-474b-736b-a8eb-a794dd88241c", "version": 1, "bodyDocId": null, "description": "Drawing the eye to one element above the rest of the slide.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:33+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9cd3-7405a163d1f2", "parentComponentId": null }, { "bbox": { "h": 0.28, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "We engaged two consultants to analyze Harmony’s cardiac safety data, one a pharmacology consultant and the second a prominent expert specifically in hERG/QT and drug-induced cardiotoxicity. The pharmacology consultant characterized Harmony’s data as “intentionally misleading” and “sneaky,” stating that the “statements made about safety margins are therefore overestimated and incorrect.” The consultant strongly disputed the FDA’s interpretation of “clinically insignificant” or “clinically manageable increases in QT at supra-therapeutic doses” as they were inferred from single-dose plasma levels vs. at steady-state.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:59.493+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "17129126-087c-4fc4-95ab-2c2addbd6aae", "parentComponentId": null }, { "bbox": { "h": 0.48, "w": 0.86, "x": 0.07, "y": 0.41 }, "kind": "quote", "text": "Basic PK – since the half-life of Pitolisant is approximately 20 hours about half the drug levels will be circulating when the 2nd dose is administered so this is added to the new peak plasma levels on Day 2, and again on day 3, day 4 etc., until steady state plasma levels are reached (for Pitolisant about 6 consecutive days of dosing - rule of thumb for half-life - it takes approximately 6 half lives of a drug to reach steady state). This is what the “accumulation ratio” parameter exemplifies In a nutshell, the peak plasma levels of Pitolisant after 6 consecutive daily doses will be 2.3x higher than they were on Day 1 but the Day 1 plasma concentrations were used to estimate the safety margins for QTcF. Thus, the QTcT study is intentionally misleading, and the statements made about safety margins are therefore overestimated and incorrect. For example, “clinically insignificant QT increases at of only 9.8 msec at 2.5x the highest therapeutic dose” BUT THIS IS TRUE ONLY AFTER A SINGLE DOSE NOT FOR MULTIPLE DAILY DOSES. These measurements should have been made at steady state after at least 6 daily doses in order for these safety margins to be accurate – they would in fact be substantially smaller (safety margins) which may account for the reported QTcF increases seen in the sleep apnea trials.” –Pharmacology consultant engaged by Scorpion Capital", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": null, "subkind": { "name": "Testimonial", "slug": "testimonial", "status": "active", "canonId": "019de52c-fc21-71b6-9ac3-8266a64945e8", "version": 1, "description": null }, "framework": null }, "subkind": "testimonial", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:59.493+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "b9e5ac11-f7e1-4d36-953c-d44e2b0c543c", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "“Basic PK – since the half-life of Pitolisant is approximately 20 hours about half the drug levels will be circulating when the 2nd dose is administered so this is added to the new peak plasma levels on Day 2, and again on day 3, day 4 etc., until steady state plasma levels are reached... Thus, the QTcT study is intentionally misleading, and the statements made about safety margins are therefore overestimated and incorrect.” — Pharmacology consultant engaged by Scorpion Capital", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:33+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9cd3-7b648574a4e8", "parentComponentId": null 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"bbox": { "h": 0.4, "w": 0.45, "x": 0.07, "y": 0.43 }, "kind": "chart", "text": "Figure 15: Goodness-of-fit plot for QTc vs steady state Cmax", "attrs": null, "canon": { "kind": { "name": "Chart", "slug": "chart", "status": "active", "canonId": "019de52c-f9a0-76ef-adc6-0b859109d1f8", "version": 1, "description": "Quantitative chart." }, "tool": null, "subkind": { "name": "Scatter plot", "slug": "scatter", "status": "active", "canonId": "019de52d-007d-72ec-8689-c79fb78e21a2", "version": 1, "description": null }, "framework": null }, "subkind": "scatter", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:59.572+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "259bd12e-468c-4bdc-9dff-33bbd0203136", "parentComponentId": null }, { "bbox": { "h": 0.15, "w": 0.86, "x": 0.07, "y": 0.22 }, "kind": "paragraph", "text": "Shockingly, the FDA CDER Clinical Pharmacology Review, in a section on pages 31 and 32 devoted to QT increases, includes a plot developed by its staff that shows QT interval increases at various plasma levels. The title of the graph states that it shows “QTc vs. steady state Cmax” – however, the data is based upon plasma levels after a SINGLE DOSE, NOT STEADY-STATE levels which are 2.3 times higher, and which means the graph is incorrect.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:17:59.572+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "48f329ed-1e1c-4170-9cf3-f3344def0d61", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "The title of the graph states that it shows “QTc vs. steady state Cmax” – however, the data is based upon plasma levels after a SINGLE DOSE, NOT STEADY-STATE levels which are 2.3 times higher, and which means the graph is incorrect. — Scorpion Capital", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:34+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9cd3-8ea2a892fdc7", "parentComponentId": null }, { "bbox": { "h": 0.02, "w": 0.4, "x": 0.07, "y": 0.88 }, "kind": "source-note", "text": "Source: IRT Review (Darrts- IRT Report, Jose Vicente Ruiz et. al., 3/22/2019).", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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"v2-canon-conditioned" } }, "links": { "slide": "/slides/019dd923-622c-750b-8b9a-21918ac10c17/133", "deck": "/decks/019dd923-622c-750b-8b9a-21918ac10c17", "deckAnchor": "/decks/019dd923-622c-750b-8b9a-21918ac10c17#slide-133", "deckJson": "/decks/019dd923-622c-750b-8b9a-21918ac10c17.json" }, "components": [ { "bbox": null, "kind": "callout", "text": "175 ng/mL and 280 ng/mL plasma levels are incorrectly labeled as “steady state” when they are merely the level after a single dose", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": { "name": "Visual emphasis", "slug": "visual-emphasis", "status": "active", "bestFor": null, "canonId": "019dd9e1-474b-736b-a8eb-a794dd88241c", "version": 1, "bodyDocId": null, "description": "Drawing the eye to one element above the rest of the slide.", "familyLabel": null }, "subkind": null, 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"promptVersion": null }, "componentId": "93e7b4e7-016c-4675-9b59-c1a7fd99929c", "parentComponentId": null }, { "bbox": { "h": 0.25, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "The same error – incorrectly using plasma levels after a single-dose but confusing them as steady-state Cmax – appears in multiple places in the FDA review document. A table immediately before the preceding graph shows a table with a column labeled “Cmax at steady state.” However, the plasma levels used to compute safety windows for the 2.5-fold and 3.8-fold dose levels are once again NOT steady state. 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0.31 }, "kind": "paragraph", "text": "“I graphed all of the single dose plasma levels vs change in TQT and created a linear regression line. The resulting equation is Y=14.62 x “X”+53.34. Solving for X (the TQT change) one can then determine the correct TQT for a certain plasma level (“Y”). The plasma levels at steady state were determined from the single dose plasma levels by multiplying by 2.3. Solving for “Y” at both the mean and the upper limit of the 95% CI (2SD). I used 51% for the plasma variability as I do not believe the other values but could easily assess using them. By this method, the actual TQT at steady state is 4.7, 22, 24, 32 and 41 ms (mean) at doses of 40, 120, 160, 200 and 240 mg. At the upper CI the TQT at steady state is 14, 49, 53, 69 and 86 ms at doses of 40, 120, 160, 200 and 240 mg, respectively at steady state. So, no, there is no safety margin using the actual data and anticipated steady state level (2.3 accumulation ratio).” – Pharmacology consultant engaged by Scorpion Capital", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:05.133+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "cd601ce5-28b3-4702-9ede-21862468d78a", "parentComponentId": null }, { "bbox": { "h": 0.03, "w": 0.86, "x": 0.07, "y": 0.27 }, "kind": "paragraph", "text": "Methodology and regression model used to correct single-dose QT data to steady-state plasma levels", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:05.133+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "e6785af1-db5f-481a-8f70-2fca7c416de2", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "“there is no safety margin using the actual data and anticipated steady state level....” — Pharmacology consultant engaged by Scorpion Capital", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:34+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9cd3-aaea262e270b", "parentComponentId": null }, { "bbox": { "h": 0.02, "w": 0.25, "x": 0.07, "y": 0.95 }, "kind": "source-note", "text": "Source: https://pubmed.ncbi.nlm.nih.gov/26879827/", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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“our laboratory findings suggest that CYP2D6 inhibition...would likely be important hurdles for this novel compound”; and that “in vitro profiling in our laboratory (and others) suggests that BF2.639 [pitolisant] has both a CYP2D6 liability...and potent hERG channel K+ blockade.”", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": { "name": "Visual emphasis", "slug": "visual-emphasis", "status": "active", "bestFor": null, "canonId": "019dd9e1-474b-736b-a8eb-a794dd88241c", "version": 1, "bodyDocId": null, "description": "Drawing the eye to one element above the rest of the slide.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:34+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9cd4-bb41cb832ef2", "parentComponentId": null }, { "bbox": { "h": 0.45, "w": 0.86, "x": 0.07, "y": 0.45 }, "kind": "list", "text": "2010 review paper, Raddatz et al; 2008 paper by Abbott scientists; 2009 paper by Evotec scientists", "attrs": null, "canon": { "kind": { "name": "List", "slug": "list", "status": "active", "canonId": "019de52c-f94b-779b-a53b-fd4904a5f4d2", "version": 1, "description": "Bullet or numbered list." }, "tool": null, "subkind": { "name": "Bullet list", "slug": "bullet", "status": "active", "canonId": "019de52c-fc98-7169-a083-5cab805076ca", "version": 1, "description": null }, "framework": null }, "subkind": "bullet", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:04.748+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "badfd341-89a7-44ba-8483-5b3c93e6985b", "parentComponentId": null }, { "bbox": { "h": 0.35, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "The CYP2D6 concerns voiced by our pharmacology consultant are consistent with the scientific literature on problems with H3 reception antagonists/inverse agonists, particularly ones with the same non-imidazole structure as pitolisant, as we discussed in a previous section. We further noted papers by pharma companies like Abbott and Evotec which synthesized pitolisant and concluded that it is plagued by severe problems including cardiotoxicity and CYP2D6 issues, and who also indicated that Bioprojet’s claims were not reproducible in their labs. We again excerpt some of those papers here: pitolisant is a “potent inhibitor of CYP2D6 and hERG”; “our laboratory findings suggest that CYP2D6 inhibition...would likely be important hurdles for this novel compound”; and that “in vitro profiling in our laboratory (and others) suggests that BF2.639 [pitolisant] has both a CYP2D6 liability...and potent hERG channel K+ blockade.”", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:04.748+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "aa5a869f-bc92-4d22-a96a-871416ab813a", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "“potent inhibitor of CYP2D6 and hERG” — Raddatz et al. “our laboratory findings suggest that CYP2D6 inhibition...would likely be important hurdles for this novel compound” — Abbott scientists. “in vitro profiling in our laboratory (and others) suggests that BF2.639 [pitolisant] has both a CYP2D6 liability...and potent hERG channel K+ blockade.” — Evotec scientists.", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:34+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9cd4-bd2031127e54", "parentComponentId": null }, { "bbox": { "h": 0.05, "w": 0.6, "x": 0.07, "y": 0.93 }, "kind": "source-note", "text": "Source: https://pubmed.ncbi.nlm.nih.gov/20166960/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2483387/pdf/bjp2008147a.pdf; https://pubmed.ncbi.nlm.nih.gov/19429511/", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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Additionally, a dedicated drug interaction study with paroxetine (a strong CYP2D6 inhibitor) also resulted in a similar increase in exposure of pitolisant which supports the conclusion that exposures can be expected to be 2x -fold higher in CYP2D6 PMs. Therefore, the dose of WAKIX should be capped at 17.8 mg/day in known CYP2D6 PMs. The details are provided in Clinical Pharmacology Questions (3.3).", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:03.044+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "5909e18a-ac4f-4f8f-adbb-29a2c1495d8d", "parentComponentId": null }, { "bbox": { "h": 0.15, "w": 0.86, "x": 0.07, "y": 0.56 }, "kind": "paragraph", "text": "12.5 Pharmacogenomics\nApproximately 3 to 10% of Caucasians and 2 to 7% of African Americans generally lack the capacity to metabolize CYP2D6 substrates and are classified as poor metabolizers. The AUC of pitolisant was approximately 2.4 times higher in CYP2D6 poor metabolizers than in normal metabolizers and is similar to the exposure of pitolisant when administered concomitantly with a CYP2D6 inhibitor [see Dosage and Administration (2.5), Drug Interactions (7.1)].\nIn CYP2D6 poor metabolizers, the Cmax of pitolisant is 153 (151 to 157) ng/mL and the AUC is 1920 (1854 to 2000) ng*hr/mL after steady state dosing with 35.6 mg once daily.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:03.044+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "b12b488f-a18f-40ec-819e-a4e0ba25d1eb", "parentComponentId": null }, { "bbox": { "h": 0.45, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "We have already noted – in the section on cardiotoxicity – that pitolisant’s steady-state plasma levels are far higher and more variable/unpredictable than asserted by Bioprojet and Harmony. Pitolisant displays a dose-dependent risk of QT prolongation and cardiovascular danger, which we believe Harmony is trying to conceal by significantly understating actual blood levels of the drug. The fact that pitolisant has a CYP2D6 liability further escalates an already significant risk, as already elevated plasma levels can spike many multiples from there. The critical question then becomes: how much do pitolisant levels increase in poor 2D6 metabolizers? The FDA relied upon an absurdly small Harmony PK study in CYP2D6 poor metabolizers (n=3) to conclude that steady-state plasma levels in such patients are twice those of normal metabolizers – 73 ng/ML in normal metabolizers at the 35.6mg dose, and 153 ng/mL in poor metabolizers – and hence recommends cutting the dose in half.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:03.044+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "d82adb2f-cad3-4e93-ba92-446912f6d3c2", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "Approximately 3 to 10% of Caucasians and 2 to 7% of African Americans generally lack the capacity to metabolize CYP2D6 substrates and are classified as poor metabolizers. The AUC of pitolisant was approximately 2.4 times higher in CYP2D6 poor metabolizers than in normal metabolizers — Pitolisant package insert.", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-23 01:18:10+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-70f3-714d-84c6-0829e39f3da2", "parentComponentId": null }, { "bbox": { "h": 0.05, "w": 0.5, "x": 0.07, "y": 0.93 }, "kind": "source-note", "text": "Source: https://www.wakix.com/assets/pdf/WAKIX_pitolisant_tablets_PI_Dec_2022.pdf; https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211150Orig1s000ClinPharmR.pdf", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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First, most patients do not know their CYP2D6 phenotype, and our interviews with 20 pitolisant prescribers indicate that no doctors are bothering to genetically test their patients. It is simply inevitable that poor metabolizers are being prescribed the max 35.6 dose – and hence the predictable spike in serious adverse events per the FDA FAERS database. Second, Harmony’s sales reps aggressively push it as an ultra-safe drug, creating even more complacency and danger. The FDA’s approach to mitigating CYP2D6-related risks – merely suggesting a smaller dose – is therefore naïve and defies clinical and commercial realities. Third, the CYP2D6 PK study upon which the FDA relied exhibits numerous red flags, consistent with what we believe to be Bioprojet’s long pattern of scientific and clinical fraud. The study results don’t appear to be published, and the full data appears to be buried and missing from even the EMA and FDA review packages. 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The red flags are obvious. First, it had only 8 patients, and only 3 were poor CYP2D6 metabolizers – in other words, the FDA’s estimate of steady-state plasma levels and dosage adjustment are based on pharmacokinetics in merely *three* poor metabolizers. The metabolic genotype/phenotype of CYP2D6 varies widely from individual to individual, leading to massive variability in plasma levels. Limiting a study to n=3 such participants suggests an attempt to cherry-pick and present misleading data that understates the variability. CYP2D6 has dozens of phenotypes, and depending on the phenotype an individual’s level of CYP2D6 function may be none, little, decreased/intermediate, normal, or rapid. 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The PK after single dose as well as after steady state (on day 7) at 40 mg dose (in salt form) was used to compare the exposure in PMs (N=3) vs NMs (N=5). CYP2D6 alleles tested and genotyping methods were appropriate for determining CYP2D6 PM and NM status. An approximate 2-fold increase in exposure was observed in CYP2D6 PMs as compared to CYP2D6 NMs. Additionally, a dedicated drug interaction study with paroxetine (a strong CYP2D6 inhibitor) also resulted in a similar increase in exposure of pitolisant which supports the conclusion that exposures can be expected to be 2-fold higher in CYP2D6 PMs.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:02.639+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "e07c390e-95bc-4b0e-ad76-8bf8d47d643f", "parentComponentId": null }, { "bbox": { "h": 0.45, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "The second red flag: Bioprojet/Harmony don't state which CYP2D6 phenotypes were selected for the three “poor” metabolizers tested – how are “poor” and “normal” defined? Further muddying the waters, the terms NM (“normal metabolizers”) and EM (“extensive metabolizers”) are used interchangeably for the 5 “normal” subjects, although the terms refer to different CYP2D6 phenotypes. The FDA’s description, which we suspect is a cut and paste summary from the company, is tellingly vague: “CYP2D6 alleles tested and genotyping methods were appropriate for determining CYP2D6 PM [poor metabolizer] and NM [normal metabolizer] status.” In the absence of this information – given the already absurd n=3 – the steady plasma estimate of poor metabolizers is meaningless. We suspect Bioprojet simply chose metabolizers with CYP2D6 phenotypes for decreased activity vs. those with little to none, thereby dramatically underestimating plasma levels.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:02.639+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "e5d0d828-c0fd-4fea-a3a7-8fbfee04ba39", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "“CYP2D6 alleles tested and genotyping methods were appropriate for determining CYP2D6 PM [poor metabolizer] and NM [normal metabolizer] status.” — FDA CDER Clinical Pharmacology Review", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:34+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9cd5-05c41d3259c5", "parentComponentId": null }, { "bbox": { "h": 0.02, "w": 0.5, "x": 0.07, "y": 0.94 }, "kind": "source-note", "text": "Source: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211150Orig1s000ClinPharmR.pdf", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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And then, while one part of the label asserts this impossibly tight range of 151 to 157 ng/mL, a chart above it is more telling with a FOUR-FOLD higher plasma level, a dangerous level of variability across just three patients. Moreover, the chart is misleading, as it uses a log scale which makes the plasma level variability in poor metabolizers look less dramatic. We note that studies have shown 30-40 fold variability in plasma levels in CYP2D6-metabolized drugs.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:03.399+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "6bf8b469-98cc-40b0-8afd-58f532e4c235", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "in CYP2D6 poor metabolizers, the Cmax of pitolisant is 153 (151 to 157) ng/mL — a range so tight that it strains credibility, leading us to wonder if Bioprojet simply chose the plasma levels they wanted and phenotyped those patients in hindsight. — Scorpion Capital", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:34+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9cd4-d590281e07fb", "parentComponentId": null }, { "bbox": { "h": 0.02, "w": 0.45, "x": 0.07, "y": 0.95 }, "kind": "source-note", "text": "Source: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211150Orig1s000ClinPharmR.pdf", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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We speculate whether Harmony may have misled the FDA, given the rampant statistical tricks across its papers and trials – using a 40mg dose to determine the plasma level in normal metabolizers, but only a 17.8mg dose in the three patients who were poor metabolizers. This would make the plasma level increase in poor metabolizers appears less worse than it is. Note below that the FDA CDER Clinical Pharmacology Review states that it was 40 mg, while the prescribing instruction in the label – which contains the graph – states that it was 17.8 mg. 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The PK after single dose as well as after steady state (on day 7) at 40 mg dose (in salt form) was used to compare the exposure in PMs (N=3) vs NMs (N=5). CYP2D6 alleles tested and\nCYP2D6 Poor Metabolizers\nThe pharmacokinetics of pitolisant were evaluated in 3 subjects who were CYP2D6 poor metabolizers (PMs) and 5 subjects who were CYP2D6 extensive metabolizers (EMs). All subjects received WAKIX 17.8 mg daily for 7 days. Exposure of pitolisant in CYP2D6 PMs is summarized in Figure 3.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": null, "framework": null }, "subkind": "description", "groupRole": null, "confidence": null, "extraction": { "at": "2026-07-17 03:28:52.771+00", "model": "google/gemini-3.1-flash-lite-preview", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "df2c9198-1618-40d5-a30a-cca32ebf11b4", "parentComponentId": null }, { "bbox": { "h": 0.04, "w": 0.6, "x": 0.07, "y": 0.94 }, "kind": "source-note", "text": "Source: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211150Orig1s000ClinPharmR.pdf; : https://www.wakix.com/assets/pdf/WAKIX_pitolisant_tablets_PI_Dec_2022.pdf", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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Even using Harmony’s asserted plasma level of 153 ng/mL – a misleadingly low number – it can spike by four-fold within a 90% CI per their own graph in the label. That results in 612 ng/mL, and far higher at a 95% CI. The expected QT prolongation at 612 ng/mL is 38 msec - well into the danger zone for cardiovascular toxicity - using the regression model developed by our pharmacology consultant using Bioprojet’s papers (see section on cardiac safety data). If, as we suspect, the CYP2D6 study used a 17.8mg dose (half the normal dose) to calculate the 153 ng/mL plasma level, then the true level is 306 ng/mL. At a four-fold change, the 306 can spike to 1224 ng/mL which leads to an expected QT prolongation of 80 msec, which of course explains the prevalence of serious cardiac events in the FDA’s adverse events database as well as potentially the cardiac-related fatality in the HAROSA sleep apnea trial. 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"019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": null, "subkind": { "name": "Primary callout", "slug": "primary", "status": "active", "canonId": "019de52c-fbd1-70eb-a9ce-8997f8674c1d", "version": 1, "description": null }, "framework": null }, "subkind": "primary", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:03.745+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "89d10d2a-c6b0-410c-84f4-036523056573", "parentComponentId": null }, { "bbox": { "h": 0.03, "w": 0.3, "x": 0.07, "y": 0.44 }, "kind": "callout", "text": "EMA pitolisant assessment report", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": null, "subkind": { "name": "Primary callout", "slug": 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substrates of CYP3A4 and CYP2D6, hormonal contraceptives, and substrates of OCT1.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:03.745+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "4ef62124-0622-4582-80a8-55fe4335d7ea", "parentComponentId": null }, { "bbox": { "h": 0.22, "w": 0.86, "x": 0.07, "y": 0.19 }, "kind": "paragraph", "text": "Both the FDA and EMA reviews list a broad range of potential interactions that can cause plasma levels to spike, SSRI’s in particular which the reviews state “are potent inhibitors of CYP2D6” and that “co-administration of pitolisant with inhibitors of CYP2D6 should be done with caution.” Our interviews with 20 prescribers indicate that virtually every patient is on multiple medications, especially SSRI’s which are extensively prescribed for narcolepsy as well as cataplexy – suggesting that a large percentage of pitolisant patients can be expected to have plasma levels at least double what’s stated as the average on the label.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:03.745+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "549bb461-2001-4ef2-a11a-41c8da163ba9", "parentComponentId": null }, { "bbox": { "h": 0.11, "w": 0.86, "x": 0.07, "y": 0.48 }, "kind": "paragraph", "text": "SSRIs are potent inhibitors of CYP2D6, pitolisant is a substrate and a weak inhibitor of CYP2D6. The inhibition of CYP2D6 by paroxetine could lead to 2-fold increase of pitolisant exposure. Given the safety profile of pitolisant from phase II and III trials, it can be concluded that co-administration of pitolisant with inhibitors of CYP2D6 should be done with caution.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:03.745+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "d6579f73-a24c-4b48-9e09-4034f1b75dac", "parentComponentId": null }, { "bbox": { "h": 0.05, "w": 0.5, "x": 0.07, "y": 0.91 }, "kind": "source-note", "text": "Source: https://www.ema.europa.eu/en/documents/assessment-report/wakix-epar-public-assessment-report_en.pdf; https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/211150Orig2s000MedR.pdf; https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211150Orig1s000OtherR.pdf", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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"callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": { "name": "Visual emphasis", "slug": "visual-emphasis", "status": "active", "bestFor": null, "canonId": "019dd9e1-474b-736b-a8eb-a794dd88241c", "version": 1, "bodyDocId": null, "description": "Drawing the eye to one element above the rest of the slide.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:35+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9cd5-ae67e5f417ee", "parentComponentId": null }, { "bbox": { "h": 0.35, "w": 0.45, "x": 0.07, "y": 0.51 }, "kind": "list", "text": "Amiodarone, Bupropion, Chlorpheniramine, Chloroquine, Chlorpromazine, Cinacalcet, Diphenhydramine, Duloxetine, Fluoxetine, Halofantrine, Haloperidol, Imatinib, Paroxetine, 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who are concurrently taking a CYP2D6 inhibiting drug like an SSRI or common OTC antihistamines.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:03.484+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "48923c9d-89c0-4a97-b7e1-8823fcba3d0d", "parentComponentId": null }, { "bbox": { "h": 0.15, "w": 0.38, "x": 0.55, "y": 0.51 }, "kind": "paragraph", "text": "Inhibitory effects of H1-antihistamines on CYP2D6- and CYP2C9-mediated drug metabolic reactions in human liver microsomes. Conclusion: All five H1-antihistamines studied inhibited CYP2D6 markedly...", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:03.484+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "e7a8c34f-685f-4908-8fa4-a8c46cae2f1f", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "Conclusion: All five H1-antihistamines studied inhibited CYP2D6 markedly... — Inhibitory effects of H1-antihistamines on CYP2D6- and CYP2C9-mediated drug metabolic reactions in human liver microsomes", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:35+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9cd5-b05aa5ac7082", "parentComponentId": null }, { "bbox": { "h": 0.03, "w": 0.5, "x": 0.07, "y": 0.94 }, "kind": "source-note", "text": "Source: https://www.pharmacytimes.com/view/2009-03-10041; https://pubmed.ncbi.nlm.nih.gov/11936702/", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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CYP2D6 inhibitor like an antihistamine DECREASES pitolisant levels, when in fact the opposite is true. 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Nine deaths occurred in the pitolisant development program; all occurred in patients receiving pitolisant (Table 35). Of the nine deaths, six occurred in male patients. 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One death was reported in the U.S. EAP, one death was reported in Study P15-11 (the European Post-Authorization Safety Study), and two deaths were reported in the Study P15-13 (the ongoing phase 3 efficacy and safety study in patients with OSA).", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:04.168+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "d362ecf9-7aba-488a-a18e-178c4fa633d8", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "nine deaths occurred in the pitolisant development program; all occurred in patients receiving pitolisant — that is,100% of fatalities were in the treatment arm and none for patients on placebo. — FDA CDER Clinical Review (Solages, Sep 28, 2020)", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:35+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9cd5-55d12438b58b", "parentComponentId": null }, { "bbox": { "h": 0.03, "w": 0.5, "x": 0.07, "y": 0.96 }, "kind": "source-note", "text": "Source: https://www.accessdata.fda.gov/drugsatsfda_docs/nda/2021/211150Orig2s000MedR.pdf", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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Although these patients had co-morbid health conditions...", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:06.747+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "05669afa-96a7-4458-a54f-1ec33de6315e", "parentComponentId": null }, { "bbox": { "h": 0.35, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "Of the 4 additional deaths, 2 were sudden deaths that could also have been heart failure, with all 4 patients on the highest dose of pitolisant (35.6mg)...", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:06.747+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "268175e5-f51f-404e-a161-5534afc00bb7", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "“an association with pitolisant cannot be ruled out.” — FDA reviewer", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:37+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9cd7-0c1e4cd89cba", "parentComponentId": null }, { "bbox": { "h": 0.03, "w": 0.4, "x": 0.07, "y": 0.94 }, "kind": "source-note", "text": "Source: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/211150Orig2s000MedR.pdf", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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The patient has a medical history that was remarkable for narcolepsy, obesity, diabetes, and hypertension. The duration of exposure to pitolisant is not included in the case report. The patient was also prescribed methylphenidate. Both pitolisant and methylphenidate were discontinued. The patient recovered.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:05.371+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "5cfdf668-900d-41ae-9e94-7c32ed2e2185", "parentComponentId": null }, { "bbox": { "h": 0.41, "w": 0.62, "x": 0.07, "y": 0.53 }, "kind": "paragraph", "text": "...and on 60-year old with dizziness, ischemic attack, and QT prolongation\n(b) (6): 60-year-old female with medical history of narcolepsy, two prior transient ischemic attacks, atherosclerosis, bilateral carotid dysplasia, hypertension, hypercholesterolemia, depression, fibromuscular dysplasia, asthma, thyroid dysfunction, angioedema, cephalalgia, and first-degree atrioventricular block at screening. She experienced sudden onset of dizziness with nausea approximately one month after the first dose of pitolisant. Accompanying symptoms included erratic gate with deviation to the right side, paresthesia of the right hemi-face, malaise, and brief loss of consciousness. Findings on clinical examination included a right carotid murmur and known muscular strength weakness on the right side; clinical examination was otherwise unremarkable. She was given a diagnosis of transient ischemic attack and discharged home on the day of presentation. She was reported to be symptom-free at the time of discharge. She continued to receive pitolisant 40 mg once daily and completed the study. Other adverse events reported during the study by this patient included prolonged QTc, nonspecific polarization abnormality, pericarditis, increased serum GGT, headache, depression, bronchitis, otitis, increased weight, and cataplexy.\nReviewer comment: This patient had a prior history of TIA and significant risk factors for TIA and stroke. The TIA resolved, and the patient was able to complete the study. No clear temporal relationship between pitolisant treatment and the onset of the adverse event is evident, although a correlation between TIA and pitolisant cannot be definitively established or ruled out based on this single case.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:05.371+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "67045ba8-8786-419c-89c8-7e65eb62d32a", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "“notable given reports of sudden death” — FDA CDER Clinical Review (Solages, Sep 28, 2020)", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:37+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9cd7-632cd941870b", "parentComponentId": null }, { "bbox": { "h": 0.03, "w": 0.45, "x": 0.07, "y": 0.95 }, "kind": "source-note", "text": "Source: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/211150Orig2s000MedR.pdf", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. Numbered footnotes use attrs.numbered." }, "tool": null, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:05.371+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "9b2f809e-d7ca-4134-a4bd-bd38bd0caaed", "parentComponentId": null }, { "bbox": { "h": 0.22, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "title", "text": "The FDA also discussed two non-fatal cardiac events: 1) a cardiac arrest in a 49-year old female, based on a European post-marketing Serious Individual Case Safety Report, where duration of pitolisant exposure wasn’t available but which was “notable given reports of sudden death” in the pitolisant sleep apnea trials; and 2) a 60-year old female with dizziness one month after starting pitolisant, transient ischemic attack, and QT prolongation, where the FDA reviewed stated a correlation with pitolisant “cannot be definitively established or ruled out.”", "attrs": null, "canon": { "kind": { "name": "Title", "slug": "title", "status": "active", "canonId": "019de52c-f7dd-76d9-b848-b1f12bd85cf4", "version": 1, "description": "Slide title or headline." }, "tool": null, "subkind": { "name": "Headline", "slug": "headline", "status": "active", "canonId": "019de52c-fae1-7463-9a7c-d60668eced0d", "version": 1, "description": null }, "framework": null }, "subkind": "headline", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:05.371+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "3ebc38fc-4168-492f-adc1-bd9ceef13f26", "parentComponentId": null } ], "metrics": [], "tools": [], "frameworks": [], "arcBeats": [], "loops": [], "locked": true }, { "page": 158, "type": "tension", "title": "The slide uses direct quotes from FDA clinical reviews to highlight the discrepancy between pre-approval assumptions and post-approval safety signals.", "function": "expose_contradiction", "rawType": "expose_contradiction", "block": null, "metadata": { "slideType": "expose_contradiction", "slideTypeCanon": { "name": "Expose contradiction", "slug": "expose_contradiction", "status": "active", "canonId": "019de52d-124c-75aa-984a-0a3d0d8fc8df", "version": 1, "description": null }, "function": "expose_contradiction", "functionCanon": { "name": "Expose contradiction", "slug": "expose_contradiction", "status": "active", "canonId": "019de52d-171f-776f-887c-73edaff4cf9c", "version": 1, "description": null }, "density": "dense", "densityScore": 53, "componentCount": 6, "textChars": 2470, "nDataPoints": 0, "notes": "The slide uses direct quotes from FDA clinical reviews to highlight the discrepancy between pre-approval assumptions and post-approval safety signals.", "elementsJson": [ "paragraph", "callout_box", "footnote" ], "confidence": 1, "extraction": { "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "at": "2026-05-02 20:18:09.501+00", "seconds": 7.929, "promptVersion": "v2-canon-conditioned" } }, "links": { "slide": "/slides/019dd923-622c-750b-8b9a-21918ac10c17/158", "deck": "/decks/019dd923-622c-750b-8b9a-21918ac10c17", "deckAnchor": "/decks/019dd923-622c-750b-8b9a-21918ac10c17#slide-158", "deckJson": "/decks/019dd923-622c-750b-8b9a-21918ac10c17.json" }, "components": [ { "bbox": { "h": 0.08, "w": 0.86, "x": 0.07, "y": 0.35 }, "kind": "callout", "text": "FDA review clearly indicates its reliance on the lack of reported serious adverse events at the time of approval in 2019 – now contradicted by the facts (FDA CDER Clinical Review (Solages, Sep 28, 2020)", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": null, "subkind": { "name": "Primary callout", "slug": "primary", "status": "active", "canonId": "019de52c-fbd1-70eb-a9ce-8997f8674c1d", "version": 1, "description": null }, "framework": null }, "subkind": "primary", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:09.501+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "7772cdef-c215-470e-b19d-ca4357415ba2", "parentComponentId": null }, { "bbox": { "h": 0.25, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "Throughout the FDA’s discussion of the fatalities, the deference afforded Harmony via the rare drug/accelerated approval pathway is evident. Despite the number of suspicious deaths, it concluded that “no clear signal for serious dysrhythmias or QT prolongation emerged in the clinical development program.” However, few patients had been exposed to pitolisant at the time and the FDA clearly relied upon the small number of serious adverse event reports. With those numbers now spiking and individual case narratives clearly indicating a safety signal, we think the FDA will be less forgiving. We note numerous statements by the FDA reviewer that are now flatly contradicted by post-approval reports.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:09.501+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "0789d785-e29b-4d56-ae9b-5eef547dc81b", "parentComponentId": null }, { "bbox": { "h": 0.18, "w": 0.86, "x": 0.07, "y": 0.44 }, "kind": "paragraph", "text": "(e.g., electrocardiogram abnormalities, increased risk of cardiovascular or respiratory events). Of note, cardiac, vascular, and pulmonary adverse events have not been reported frequently in the postmarketing period (see Postmarketing Data), either in the United States or in Europe (where pitolisant has been available for more than 4 years). A thorough QT (TQT) study submitted to the association with pitolisant exposure has not been established. Cardiovascular and pulmonary adverse reactions were infrequently reported in the postmarketing period, both in the United States and in Europe (where pitolisant has been available since 2016). In patients with", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:09.501+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "580f4855-d4d5-40f3-9e16-dfdb59db6473", "parentComponentId": null }, { "bbox": { "h": 0.25, "w": 0.86, "x": 0.07, "y": 0.64 }, "kind": "quote", "text": "Reviewer comment: Based on the clinical information presented, the reported TEAE of prolonged QT may have been spurious. No clear signal for serious dysrhythmias or QT prolongation emerged in the clinical development program. Patients in the dementia and Parkinson's disease trials reported cardiovascular adverse events including cardiac failure, myocardial infarction, hypertension, and angina. Most of these patients had underlying risk factors for cardiovascular disease and most of these events occurred in the open-label phase of the clinical trials. Therefore, whether there is a correlation between pitolisant and these other cardiovascular events is unclear.", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": null, "subkind": { "name": "Pull quote", "slug": "pull-quote", "status": "active", "canonId": "019de52c-fbf9-76fe-97e1-a0b7540445c9", "version": 1, "description": null }, "framework": null }, "subkind": "pull-quote", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:09.501+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "0c4fd128-ccdd-4a97-9145-e7fa1d1982d1", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "No clear signal for serious dysrhythmias or QT prolongation emerged in the clinical development program. — FDA CDER Clinical Review (Solages, Sep 28, 2020)", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:36+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9cd5-f8718f2818d8", "parentComponentId": null }, { "bbox": { "h": 0.03, "w": 0.4, "x": 0.07, "y": 0.94 }, "kind": "source-note", "text": "Source: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/211150Orig2s000MedR.pdf", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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null, "subkind": { "name": "Primary callout", "slug": "primary", "status": "active", "canonId": "019de52c-fbd1-70eb-a9ce-8997f8674c1d", "version": 1, "description": null }, "framework": null }, "subkind": "primary", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:05.87+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "a8dc9c41-837f-4b6d-bed5-abc9f487bbe2", "parentComponentId": null }, { "bbox": { "h": 0.15, "w": 0.86, "x": 0.07, "y": 0.58 }, "kind": "paragraph", "text": "A reported ICSR of epilepsy is notable given the nonclinical findings and prior reports of epilepsy in the postmarketing period. The serious ICSR of epilepsy concerned a 36-year-old female patient with a prior medical history of epilepsy who experienced increased frequency of seizures after exposure to pitolisant. Pitolisant was discontinued after 2 months of treatment. The outcome of the case is unknown.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:05.87+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "2f861a38-b3d1-49cb-8ddc-6d6a53c0277a", "parentComponentId": null }, { "bbox": { "h": 0.15, "w": 0.86, "x": 0.07, "y": 0.75 }, "kind": "paragraph", "text": "Seizures and convulsions are also adverse events of special interest for this application; however, none of these events were reported as serious adverse events in narcolepsy clinical trials. Because seizures and cardiovascular events are of special interest in this development program, the SAE of transient ischemic attack (reported by one patient in the HARMONY III trial) is also notable. A summary of the case narrative is below.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:05.87+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "8600add7-bc8e-4b83-8e87-460e4e8212db", "parentComponentId": null }, { "bbox": { "h": 0.2, "w": 0.86, "x": 0.07, "y": 0.27 }, "kind": "paragraph", "text": "The FDA conveys its keen interest in “seizures and convulsions” several times – which we think is problematic for Harmony for two reasons. First, the FDA’s database now contains a number of serious adverse event reports related to seizures, indicating a safety signal; and two, seizures are often one of the first symptoms of QT prolongation. We note a paper on the subject: “long QT syndrome accompanied by a seizure episode is often misdiagnosed as primary epilepsy.”", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:05.87+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "b3716932-9331-4284-bc38-f487e4a66473", "parentComponentId": null }, { "bbox": { "h": 0.15, "w": 0.86, "x": 0.07, "y": 0.16 }, "kind": "paragraph", "text": "The FDA also noted a seizure in a European post-marketing Serious Individual Case Safety Report, stating that while none were observed in clinical trials, that the case report “is notable” and that “seizures and cardiovascular events are of special interest.”", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:05.87+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "cc5b5c22-c4e5-4e95-9aea-5bfdb658e2bc", "parentComponentId": null }, { "bbox": { "h": 0.15, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "QT prolongation and cardiac events are not the only ones where the FDA’s reviews indicate the agency’s skittishness and a wait-and-see posture pending safety signals from the post-marketing period.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:05.87+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "db8a8f84-89e8-486d-9592-93a05ad7300f", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "“seizures and cardiovascular events are of special interest.” — FDA", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:36+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9cd6-136ae28a99ef", "parentComponentId": null }, { "bbox": { "h": 0.03, "w": 0.75, "x": 0.07, "y": 0.95 }, "kind": "source-note", "text": "Source: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/211150Orig2s000MedR.pdf; https://journals.sagepub.com/doi/full/10.1177/1024907918754921", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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The patient who experienced hepatic enzyme elevation recovered after an over-the-counter supplement was discontinued.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:04.903+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "12d4f8f2-66cf-40d1-a2d9-1348df431f44", "parentComponentId": null }, { "bbox": { "h": 0.25, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "Additional evidence of pitolisant’s liver toxicity is buried in the FDA review, in a brief discussion of a pitolisant phase 1 PK study for Prader-Willi Syndrome. One of eight pediatric patients “experienced hepatic enzyme elevation.” Like other Harmony/Bioprojet PK studies, we can locate no further information on the study much less a paper. The study doesn’t even to have a ClinicalTrials.gov entry, making it impossible to know which enzyme, the dose that triggered it, how long after treatment, or when the study was undertaken", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:04.903+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "7ea59176-c7a9-4c89-a894-ed4186998ed8", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "“experienced hepatic enzyme elevation.” — FDA review", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:36+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9cd6-70b239087561", "parentComponentId": null }, { "bbox": { "h": 0.02, "w": 0.45, "x": 0.07, "y": 0.93 }, "kind": "source-note", "text": "Source: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/211150Orig2s000MedR.pdf", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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0.775, "x": 0.073, "y": 0.068 }, "kind": "title", "text": ">Hypereosinophilic syndrome and drug-induced phospholipidosis overlooked by FDA", "attrs": null, "canon": { "kind": { "name": "Title", "slug": "title", "status": "active", "canonId": "019de52c-f7dd-76d9-b848-b1f12bd85cf4", "version": 1, "description": "Slide title or headline." }, "tool": null, "subkind": { "name": "Headline", "slug": "headline", "status": "active", "canonId": "019de52c-fae1-7463-9a7c-d60668eced0d", "version": 1, "description": null }, "framework": null }, "subkind": "headline", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:04.305+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "c9941ce6-c137-4bcd-8820-cd903233bb01", "parentComponentId": null } ], "metrics": [], "tools": [], "frameworks": [], "arcBeats": [], "loops": [], "locked": true }, { "page": 163, "type": "tension", "title": "The slide uses a 'villain' narrative to frame the company's non-disclosure as intentional concealment.", "function": "expose_contradiction", "rawType": "expose_contradiction", "block": null, "metadata": { "slideType": "expose_contradiction", "slideTypeCanon": { "name": "Expose contradiction", "slug": "expose_contradiction", "status": "active", "canonId": "019de52d-124c-75aa-984a-0a3d0d8fc8df", "version": 1, "description": null }, "function": "expose_contradiction", "functionCanon": { "name": "Expose contradiction", "slug": "expose_contradiction", "status": "active", "canonId": "019de52d-171f-776f-887c-73edaff4cf9c", "version": 1, "description": null }, "density": "balanced", "densityScore": 49, "componentCount": 5, "textChars": 1698, "nDataPoints": 6, "notes": "The slide uses a 'villain' narrative to frame the company's non-disclosure as intentional concealment.", "elementsJson": [ "paragraph", "callout_box", "footnote" ], "confidence": 1, "extraction": { "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "at": "2026-05-02 20:18:06.484+00", "seconds": 4.076, "promptVersion": "v2-canon-conditioned" } }, "links": { "slide": "/slides/019dd923-622c-750b-8b9a-21918ac10c17/163", "deck": "/decks/019dd923-622c-750b-8b9a-21918ac10c17", "deckAnchor": "/decks/019dd923-622c-750b-8b9a-21918ac10c17#slide-163", "deckJson": "/decks/019dd923-622c-750b-8b9a-21918ac10c17.json" }, "components": [ { "bbox": { "h": 0.03, "w": 0.55, "x": 0.07, "y": 0.55 }, "kind": "callout", "text": "EMA review indicated hypoeosinophilia in 13% of pitolisant patients", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": null, "subkind": { "name": "Primary callout", "slug": "primary", "status": "active", "canonId": "019de52c-fbd1-70eb-a9ce-8997f8674c1d", "version": 1, "description": null }, "framework": null }, "subkind": "primary", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:06.484+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "30c9a2d4-cd43-447b-8452-3b17d0bfc50c", "parentComponentId": null }, { "bbox": { "h": 0.45, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "Throughout our investigation, we consistently observed a pattern where Harmony and Bioprojet are evasive and conceal information, particularly in relation to significant adverse events. The EMA’s safety review – buried on page 76 of a 102 page document - noted a startling safety signal absent in the FDA review – “abnormal levels of eosinophils” in pitolisant patients, affecting 16.1% of those in the treatment arm in the Harmony 1 trial. Four of 32 pitolisant patients (13%) “were described as hypoeosinophilia” (sic – hyper). The paper for the Harmony 1 trial, in the paragraph on adverse events, makes no mention of eosinophils, not even indirectly. The EMA appears to have had access to additional data that the FDA didn’t, and then takes the company’s explanation at face value: “This was not associated with any specific adverse events.” In our experience, companies only conceal data that they’re worried about, and are more forthcoming if it’s as innocuous as stated.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:06.484+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "ad6317fc-74fe-4592-8cae-1c9a767d9bf3", "parentComponentId": null }, { "bbox": { "h": 0.15, "w": 0.86, "x": 0.07, "y": 0.59 }, "kind": "paragraph", "text": "In study Harmony I (P07-03) there was a higher proportion of patients in the pitolisant group with abnormal levels of eosinophils compared to placebo and modafinil groups, at V1 (respectively 16.1% vs 6.7% and 6.1%, p-value=0.454) and at V7 (respectively 16.1% vs 6.7% and 0%, p-value=0.027). The four cases with abnormal levels of eosinophils under pitolisant treatment were described as hypoeosinophilia. This was not associated with any specific adverse events.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:06.484+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "bc96a10d-65d0-45c4-b9f0-8c790e2a584c", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "“This was not associated with any specific adverse events.” — EMA assessment report", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:36+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9cd5-e149b272c905", "parentComponentId": null }, { "bbox": { "h": 0.02, "w": 0.55, "x": 0.07, "y": 0.93 }, "kind": "source-note", "text": "Source: https://www.ema.europa.eu/en/documents/assessment-report/wakix-epar-public-assessment-report_en.pdf", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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a combination of original analysis and cited medical literature to challenge the transparency of clinical trial reporting.", "function": "expose_contradiction", "rawType": "preempt_rebuttal", "block": null, "metadata": { "slideType": "preempt_rebuttal", "slideTypeCanon": { "name": "Preempt rebuttal", "slug": "preempt_rebuttal", "status": "active", "canonId": "019de52d-1225-7368-af32-6381fddabdb3", "version": 1, "description": null }, "function": "expose_contradiction", "functionCanon": { "name": "Expose contradiction", "slug": "expose_contradiction", "status": "active", "canonId": "019de52d-171f-776f-887c-73edaff4cf9c", "version": 1, "description": null }, "density": "dense", "densityScore": 72, "componentCount": 8, "textChars": 2170, "nDataPoints": 1, "notes": "The slide uses a combination of original analysis and cited medical literature to challenge the transparency of clinical trial reporting.", "elementsJson": [ "paragraph", "footnote" ], "confidence": 0.95, "extraction": { "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "at": "2026-05-02 20:18:06.748+00", "seconds": 4.236, "promptVersion": "v2-canon-conditioned" } }, "links": { "slide": "/slides/019dd923-622c-750b-8b9a-21918ac10c17/164", "deck": "/decks/019dd923-622c-750b-8b9a-21918ac10c17", "deckAnchor": "/decks/019dd923-622c-750b-8b9a-21918ac10c17#slide-164", "deckJson": "/decks/019dd923-622c-750b-8b9a-21918ac10c17.json" }, "components": [ { "bbox": { "h": 0.03, "w": 0.55, "x": 0.07, "y": 0.71 }, "kind": "callout", "text": "Lungs are a frequent target of hypereosinophilia – example papers", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": null, "subkind": { "name": "Primary callout", "slug": "primary", "status": "active", "canonId": "019de52c-fbd1-70eb-a9ce-8997f8674c1d", "version": 1, "description": null }, "framework": null }, "subkind": "primary", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:06.748+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "011c0088-5e6a-4888-b03b-ceda2af21b8d", "parentComponentId": null }, { "bbox": { "h": 0.03, "w": 0.55, "x": 0.07, "y": 0.48 }, "kind": "callout", "text": "Hypereosinophilic syndrome “may intrinsically cause tissue and organ damage”", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": null, "subkind": { "name": "Primary callout", "slug": "primary", "status": "active", "canonId": "019de52c-fbd1-70eb-a9ce-8997f8674c1d", "version": 1, "description": null }, "framework": null }, "subkind": "primary", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:06.748+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "4ddf3d9c-6fe7-42f8-b25e-2b17ffa74a73", "parentComponentId": null }, { "bbox": null, "kind": "callout", "text": "Furthermore, we could locate no mention of hypereosinophilia in any of Bioprojet’s or Harmony’s papers or trials, so we assume they covered it up and/or just stopped measuring it in later studies.", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": { "name": "Visual emphasis", "slug": "visual-emphasis", "status": "active", "bestFor": null, "canonId": "019dd9e1-474b-736b-a8eb-a794dd88241c", "version": 1, "bodyDocId": null, "description": "Drawing the eye to one element above the rest of the slide.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:36+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9cd6-2314fce4bf4a", "parentComponentId": null }, { "bbox": { "h": 0.1, "w": 0.4, "x": 0.07, "y": 0.75 }, "kind": "list", "text": "Lung involvement in hypereosinophilic syndromes\nHypereosinophilic syndromes and lung involvement", "attrs": null, "canon": { "kind": { "name": "List", "slug": "list", "status": "active", "canonId": "019de52c-f94b-779b-a53b-fd4904a5f4d2", "version": 1, "description": "Bullet or numbered list." }, "tool": null, "subkind": { "name": "Bullet list", "slug": "bullet", "status": "active", "canonId": "019de52c-fc98-7169-a083-5cab805076ca", "version": 1, "description": null }, "framework": null }, "subkind": "bullet", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:06.748+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "3a9903c8-eb66-403b-9b5e-f905f87069bd", "parentComponentId": null }, { "bbox": { "h": 0.35, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "The brief EMA mention of hyper-eosinophilia contains no information as to how abnormal the eosinophil count was or whether a tissue biopsy accompanied the blood panel to measure tissue infiltration – “hypereosinophilia is often but not uniformly associated with eosinophilic infiltration of tissues that can potentially lead to irreversible, life-threatening organ damage.” Furthermore, we could locate no mention of hypereosinophilia in any of Bioprojet’s or Harmony’s papers or trials, so we assume they covered it up and/or just stopped measuring it in later studies. Eosinophils are white blood cells that are part of the immune system, typically associated with inflammation. The clinical literature indicates that the lungs are a common target of hypereosinophilic syndrome, and that cardiopulmonary abnormality manifests in >70% of patients.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:06.748+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "5ef4fb80-0f05-4d73-a116-a0ccca5df9ad", "parentComponentId": null }, { "bbox": { "h": 0.15, "w": 0.86, "x": 0.07, "y": 0.52 }, "kind": "paragraph", "text": "Markedly increased blood eosinophilia, ≥1.5 × 10⁹/L, whether discovered fortuitously or found with signs and symptoms of associated organ involvement, commands diagnostic evaluation and often therapeutic interventions. This degree of hypereosinophilia is often, but not uniformly, associated with eosinophilic infiltration of tissues that can potentially lead to irreversible, life-threatening organ damage. Initial approaches focus on ascertaining that eosinophilia is not secondary to other", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:06.748+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "a27fa367-4ecd-45be-bbac-3be0dda4c395", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "“hypereosinophilia is often but not uniformly associated with eosinophilic infiltration of tissues that can potentially lead to irreversible, life-threatening organ damage.” — Unattributed medical literature", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:36+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9cd6-266d60534d82", "parentComponentId": null }, { "bbox": { "h": 0.05, "w": 0.65, "x": 0.07, "y": 0.93 }, "kind": "source-note", "text": "Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2902584/; https://www.resmedjournal.com/article/S0954-6111(10)00414-2/fulltext; https://www.ers-education.org/lr/show-details/?idP=254844", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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Leukocytes adhesion to endothelial cells is one of the most critical event in the inflammatory response. In presented paper using a relevant model of adhesion we have demonstrated that histamine influence eosinophils adhesion to endothelium. 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Compared pharmacology of human histamine H3 and H4 receptors: structure–activity relationships of histamine derivatives et al., 2001). 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We see two obvious areas of concern, either or both of which may be responsible: 1) off-target effects related to the H4 receptor, and 2) drug-induced phospholipidosis, a known aspect of pitolisant’s toxicity profile, which we get to in a few slides and which has been swept under the rug. Pitolisant targets the H3 receptor, which has low sequence homology with the h1 and h2 receptors which limits off-target effects. However, the H3 and H4 receptors have similar homology, which makes it difficult to target the H3 receptor without also impacting the H4 receptor. 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"deckJson": "/decks/019dd923-622c-750b-8b9a-21918ac10c17.json" }, "components": [ { "bbox": null, "kind": "callout", "text": "We note that the package insert says that the drug \"has no appreciable binding to other histamine receptors,\" but the only source appears to be a 2006 preclinical paper by Bioprojet scientist Xavier Ligneau, a member of Schwartz’s inner circle and whose work other scientists have stated is not reproducible in their labs, leading us to take his papers with a grain of salt.", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": { "name": "Visual emphasis", "slug": "visual-emphasis", "status": "active", "bestFor": null, "canonId": "019dd9e1-474b-736b-a8eb-a794dd88241c", "version": 1, "bodyDocId": null, "description": "Drawing the eye to one element above the rest of the slide.", "familyLabel": null }, 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He tested a number of compounds (including Bioprojet’s) that target the H3 receptor and showed that they are also generally potent at the H4 receptor, as displayed in the table. He did not test pitolisant. We note that the package insert says that the drug “has no appreciable binding to other histamine receptors,” but the only source appears to be a 2006 preclinical paper by Bioprojet scientist Xavier Ligneau, a member of Schwartz’s inner circle and whose work other scientists have stated is not reproducible in their labs, leading us to take his papers with a grain of salt.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:07.033+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "fcad5bec-cb15-4677-9fcd-f21271f323e8", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "“has no appreciable binding to other histamine receptors,” — Harmony Biosciences package insert", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:36+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9cd6-3fd296bee679", "parentComponentId": null }, { "bbox": { "h": 0.02, "w": 0.65, "x": 0.07, "y": 0.93 }, "kind": "source-note", "text": "Source: https://pubmed.ncbi.nlm.nih.gov/26939881/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1751501/pdf/147-0706666a.pdf", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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history of narcolepsy, sleep apnea, diabetes, hypertension, and overweight died of pulmonary edema. The patient began receiving pitolisant on (b)(6), and was receiving a dose of 35.6 mg. The patient’s concomitant medications included venlafaxine, modafinil, clonazepam, metformin, and nebivolol. Death occurred on (b)(6). No autopsy was performed. The Investigator assessed the event as unrelated to pitolisant.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:11.423+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "1d62c159-c222-45b2-ac1e-7468a1b2e07d", "parentComponentId": null }, { "bbox": { "h": 0.3, "w": 0.86, "x": 0.07, "y": 0.51 }, "kind": "paragraph", "text": "Reviewer Comment: Since the original NDA review, two deaths have occurred in pitolisant-treated patients with narcolepsy. The patient who died by suicide had previously experienced a relapse of bipolar disorder symptoms a month after initiating treatment with pitolisant. However, he reportedly recovered from the exacerbation of bipolar symptoms and continued pitolisant treatment without complications for almost 1 year afterwards. The suicide occurred in the context significant life stressors. The information in the case narrative does not suggest a clear link between pitolisant treatment and the suicide. The second patient died of pulmonary edema. The patient had other co-occurring conditions that could have plausibly increased the risk of developing pulmonary edema. No clear association between pitolisant and pulmonary edema is apparent in this narrative.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:11.423+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "d4567dfe-5926-42e7-8981-03c04296fbe0", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "“No clear association between pitolisant and pulmonary edema is apparent in this narrative.” — FDA CDER Clinical Review (Solages, Sep 28, 2020)", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:36+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9cd6-89b488331fd2", "parentComponentId": null }, { "bbox": { "h": 0.02, "w": 0.45, "x": 0.07, "y": 0.95 }, "kind": "source-note", "text": "Source: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/211150Orig2s000MedR.pdf", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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Numbered footnotes use attrs.numbered." }, "tool": null, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:11.423+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "61d36881-f556-4e97-9ed6-1105bb4004d7", "parentComponentId": null }, { "bbox": { "h": 0.15, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "title", "text": "A seventh fatality was due to “pulmonary edema,” a textbook symptom of hypereosinophilia. The FDA’s review exhibited zero awareness of the hypereosinophilia signal and failed to draw any potential link: “No clear association between pitolisant and pulmonary edema is apparent in this narrative.”", "attrs": null, "canon": { "kind": { "name": "Title", "slug": "title", "status": "active", "canonId": "019de52c-f7dd-76d9-b848-b1f12bd85cf4", "version": 1, "description": "Slide title or headline." }, "tool": null, "subkind": { "name": "Action title", "slug": "action-title", "status": "active", "canonId": "019de52c-fb31-734c-a0f5-a3935b73135d", "version": 1, "description": null }, "framework": null }, "subkind": "action-title", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:11.423+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "783e7d42-cf16-4a32-bf5d-2dc1dd8b8818", "parentComponentId": null } ], "metrics": [], "tools": [], "frameworks": [ { "matchId": 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"deckJson": "/decks/019dd923-622c-750b-8b9a-21918ac10c17.json" }, "components": [ { "bbox": null, "kind": "callout", "text": "Similarly, neither the FDA nor EMA ever mentioned the risk of drug-induced phospholipidosis, which causes inflammatory reactions – which are of course associated with elevated eosinophils.", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": { "name": "Visual emphasis", "slug": "visual-emphasis", "status": "active", "bestFor": null, "canonId": "019dd9e1-474b-736b-a8eb-a794dd88241c", "version": 1, "bodyDocId": null, "description": "Drawing the eye to one element above the rest of the slide.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:36+00", "model": "unknown-legacy", "runId": null, 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"runId": null, "seconds": null, "promptVersion": null }, "componentId": "1f383ca3-6e4e-4070-871e-344264d2785c", "parentComponentId": null }, { "bbox": { "h": 0.35, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "Similarly, neither the FDA nor EMA ever mentioned the risk of drug-induced phospholipidosis, which causes inflammatory reactions – which are of course associated with elevated eosinophils. Pitolisant trials and papers are also radio silent on phospholipidosis. which is highlighted in the literature on H3 receptor antagonists/inverse agonists as a toxicity inherent to the class, particularly drug candidates with a piperidine ring as is the case with pitolisant. Drug-induced phospholipidosis is characterized by the pathological accumulation of phospholipids (fatty molecules) in the tissues, particularly in the lungs given the association of pneumocytes (cells that comprise most of the inner surface of the lungs).", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:07.588+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "818af142-b2b7-45ea-af2a-7c58ee3b19cb", "parentComponentId": null }, { "bbox": { "h": 0.12, "w": 0.86, "x": 0.07, "y": 0.53 }, "kind": "paragraph", "text": "Abstract Drug-induced phospholipidosis is characterized by intracellular accumulation of phospholipids with lamellar bodies, most likely from an impaired phospholipid metabolism of the lysosome. Organs affected by phospholipidosis exhibit inflammatory reactions and histopathological changes. Despite significant", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:07.588+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "a006796c-f88b-46b6-850e-7704cd86743c", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "Drug-induced phospholipidosis is characterized by intracellular accumulation of phospholipids with lamellar bodies, most likely from an impaired phospholipid metabolism of the lysosome. Organs affected by phospholipidosis exhibit inflammatory reactions and histopathological changes. — Research literature on drug-induced phospholipidosis", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:36+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9cd6-c795f51b6fd7", "parentComponentId": null }, { "bbox": { "h": 0.02, "w": 0.45, "x": 0.07, "y": 0.94 }, "kind": "source-note", "text": "Source: https://febs.onlinelibrary.wiley.com/doi/10.1016/j.febslet.2006.08.061", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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uses two distinct text columns to present evidence from 2008 and 2009 papers regarding the toxicity profile of H3R compounds.", "elementsJson": [ "paragraph", "screenshot", "footnote" ], "confidence": 0.9, "extraction": { "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "at": "2026-05-02 20:18:07.346+00", "seconds": 3.45, "promptVersion": "v2-canon-conditioned" } }, "links": { "slide": "/slides/019dd923-622c-750b-8b9a-21918ac10c17/171", "deck": "/decks/019dd923-622c-750b-8b9a-21918ac10c17", "deckAnchor": "/decks/019dd923-622c-750b-8b9a-21918ac10c17#slide-171", "deckJson": "/decks/019dd923-622c-750b-8b9a-21918ac10c17.json" }, "components": [ { "bbox": null, "kind": "callout", "text": "As noted in a previous section, several pharmaceutical companies with H3R program synthesized pitolisant as part of their research, and specifically noted the drug's \"potential for phospholipidosis\" as one of many \"important hurdles for this novel compound.\"", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": { "name": "Visual emphasis", "slug": "visual-emphasis", "status": "active", "bestFor": null, "canonId": "019dd9e1-474b-736b-a8eb-a794dd88241c", "version": 1, "bodyDocId": null, "description": "Drawing the eye to one element above the rest of the slide.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:37+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9cd7-423227b07cda", "parentComponentId": null }, { "bbox": { "h": 0.45, "w": 0.42, "x": 0.51, "y": 0.41 }, "kind": "paragraph", "text": "Whilst the majority of non-imidazole classes of H3R antagonists appear not to inhibit significantly the CYP family of enzymes, many H3R antagonist programmes have reportedly suffered from significant blockade of the hERG K+ channel [43–45] or have demonstrated the potential for phospholipidosis [43,46] or they have wrestled with P-gp substrate problems. As an example, Abbott's pre-clinical candidate ABT-239 (Table 1) is reported to exhibit strong binding to the hERG K+ channel (Ki = 0.45 nM; 420-fold selectivity H3R/hERG) that manifested itself in a dose-dependent QTc prolongation in dog (Altenbach, personal communication) and monkey [47]. In addition, the compound was also reported to cause phospholipidosis. The combination of these two factors is probably what led to the compound's demise.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:07.346+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "1d884cca-af4e-4a18-a7da-17502e49e6b4", "parentComponentId": null }, { "bbox": { "h": 0.25, "w": 0.42, "x": 0.07, "y": 0.41 }, "kind": "paragraph", "text": "these species. BF2.649 is presently under clinical investigation in several Phase II trials for the treatment of schizophrenia, ADHD, dementia and Parkinson's disease. (www.stanleyresearch.org/programs/trialgrants.htm). From the development point of view, our laboratory findings suggest that CYP2D6 inhibition, potent hERG binding and the potential for phospholipidosis would likely be important hurdles for this novel compound.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:07.346+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "212361cc-03b5-468f-81b4-e4bd54d91fa7", "parentComponentId": null }, { "bbox": { "h": 0.25, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "The literature on drug-induced phospholipidosis indicates that it is caused by a particular molecular feature shared by certain drugs (“cationic amphilic drugs”), and is inherent to H3 receptor antagonist/inverse agonist programs. As noted in a previous section, several pharmaceutical companies with H3R program synthesized pitolisant as part of their research, and specifically noted the drug’s “potential for phospholipidosis” as one of many “important hurdles for this novel compound.”", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:07.346+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "a39e85ad-2f0d-4ac9-9cdd-25992fd0b933", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "\"potential for phospholipidosis\" — Abbott researchers (2008 paper). \"The combination of these two factors is probably what led to the compound's demise.\" — 2009 paper regarding ABT-239.", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:37+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9cd7-46d6076d0aad", "parentComponentId": null }, { "bbox": { "h": 0.03, "w": 0.6, "x": 0.07, "y": 0.93 }, "kind": "source-note", "text": "Source https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2483387/pdf/bjp2008147a.pdf; https://pubmed.ncbi.nlm.nih.gov/19429511/", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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“the results can be deadly” - by using a case study of a 62-year old woman who was admitted to a hospital “with difficulty breathing.” The condition was incorrectly assessed as bronchitis but was found to be drug-induced. We note the similarity of the narrative to those in the fatalities table for pitolisant trials, where pulmonary involvement is prevalent.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:07.717+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "8e38d38b-32d5-4986-bf11-efb10b5c733a", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "“the seriousness of DIPL” - “the results can be deadly” — Gonzalez-Rothi et al.", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:37+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9cd7-ea59cb41f31a", "parentComponentId": null }, { "bbox": { "h": 0.02, "w": 0.37, "x": 0.07, "y": 0.94 }, "kind": "source-note", "text": "Source: https://www.echelon-inc.com/drug-induced-phospholipidosis/", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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"canonId": "019de52c-fec4-7221-986b-1cb5f5e84b1f", "version": 1, "description": null }, "framework": null }, "subkind": "bar-horizontal", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:11.047+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "979373c4-0ca4-4cc6-bb2e-61e5b79fedb6", "parentComponentId": null }, { "bbox": null, "kind": "metric", "text": "Adverse Event Reports: 612", "attrs": null, "canon": { "kind": { "name": "Metric", "slug": "metric", "status": "active", "canonId": "019de52c-f923-73bf-8081-d0b1a8c5264d", "version": 1, "description": "Big-number or KPI value." }, "tool": { "name": "Quantification", "slug": "quantification", "status": "active", "bestFor": null, "canonId": "019dd9e1-47ab-72ce-a079-aab1f5299e88", "version": 1, "bodyDocId": null, "description": "Translating a claim into numbers, charts, or tables.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": "primary", "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:37+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9cd7-26f4fb690228", "parentComponentId": null }, { "bbox": { "h": 0.32, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "The FDA Adverse Events Reporting System (FAERS) indicates 612 case reports for pitolisant/Wakix through Dec 31, 2022, almost all from 2019 to 2022, despite the relatively small number of patients who have taken the drug. We think lags in the database and/or reporting games by Harmony mean the number of actual case reports in the last two years is several-fold higher, as we shall explain. Of these, 80% (~470 cases) are nervous system and psychiatric and 130 are gastrointestinal. We note 64 respiratory/thoracic and 26 cardiac reports, which are particularly of note given evidence of pitolisant's cardiotoxicity and the cardiopulmonary-nature of most of the fatalities during clinical trials.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:11.047+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "43123d0c-3366-4a99-a25e-69b1b93a197a", "parentComponentId": null }, { "bbox": { "h": 0.03, "w": 0.86, "x": 0.07, "y": 0.4 }, "kind": "source-note", "text": "Data and charts from FDA FAERS for search terms Wakix/pitolisant/pitolisant hydrochloride", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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"019de52d-171f-776f-887c-73edaff4cf9c", "version": 1, "description": null }, "density": "dense", "densityScore": 58, "componentCount": 6, "textChars": 1771, "nDataPoints": 25, "notes": "The slide uses a list of adverse events to build a case for cardiotoxicity, highlighting specific fatal and serious outcomes.", "elementsJson": [ "paragraph", "bullet_list" ], "confidence": 1, "extraction": { "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "at": "2026-05-02 20:18:07.313+00", "seconds": 2.829, "promptVersion": "v2-canon-conditioned" } }, "links": { "slide": "/slides/019dd923-622c-750b-8b9a-21918ac10c17/175", "deck": "/decks/019dd923-622c-750b-8b9a-21918ac10c17", "deckAnchor": "/decks/019dd923-622c-750b-8b9a-21918ac10c17#slide-175", "deckJson": "/decks/019dd923-622c-750b-8b9a-21918ac10c17.json" }, "components": [ { "bbox": { "h": 0.04, "w": 0.86, "x": 0.07, "y": 0.48 }, "kind": "callout", "text": "Serious adverse event reports which contain the following symptoms or combinations of symptoms", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": null, "subkind": { "name": "Primary callout", "slug": "primary", "status": "active", "canonId": "019de52c-fbd1-70eb-a9ce-8997f8674c1d", "version": 1, "description": null }, "framework": null }, "subkind": "primary", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:07.313+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "b56592d6-ba10-468c-bca1-2d78a1751119", "parentComponentId": null }, { "bbox": null, "kind": "callout", "text": "Below we list the large number of serious adverse events which indicate cardiotoxicity – generally requiring hospitalization.", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": { "name": "Visual emphasis", "slug": "visual-emphasis", "status": "active", "bestFor": null, "canonId": "019dd9e1-474b-736b-a8eb-a794dd88241c", "version": 1, "bodyDocId": null, "description": "Drawing the eye to one element above the rest of the slide.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:37+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9cd6-da863ada89d7", "parentComponentId": null }, { "bbox": { "h": 0.42, "w": 0.86, "x": 0.07, "y": 0.52 }, "kind": "list", "text": "Myocardial infarction/dizziness – fatal (1)\nCardiac arrest (1)\nMyocardial infarction/loss of consciousness/cardiac disorder (1)\nLoss of consciousness (1)\nDizziness/irregular heartbeat/blurry vision (7)\nHypertension/tachycardia (8)\nPalpitations/chest pain (4)\nSeizure/QT prolongation per ECG/delirium (1)\nAbnormal QT interval per ECG (1)\nSeizure (2)\nAtrial fibrillation (1)\nPericarditis (1)\nIschemic stroke (1)\nMyocarditis (1)\nChest pain/vomiting (1)\nTachycardia/palpitations/cardiac disorder (1)\nVertigo/hypertension (1)", "attrs": null, "canon": { "kind": { "name": "List", "slug": "list", "status": "active", "canonId": "019de52c-f94b-779b-a53b-fd4904a5f4d2", "version": 1, "description": "Bullet or numbered list." }, "tool": null, "subkind": { "name": "Bullet list", "slug": "bullet", "status": "active", "canonId": "019de52c-fc98-7169-a083-5cab805076ca", "version": 1, "description": null }, "framework": null }, "subkind": "bullet", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:07.313+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "96d07dff-b10a-49f0-975b-4d4faf3947eb", "parentComponentId": null }, { "bbox": null, "kind": "metric", "text": "serious adverse events: 137", "attrs": null, "canon": { "kind": { "name": "Metric", "slug": "metric", "status": "active", "canonId": "019de52c-f923-73bf-8081-d0b1a8c5264d", "version": 1, "description": "Big-number or KPI value." }, "tool": { "name": "Quantification", "slug": "quantification", "status": "active", "bestFor": null, "canonId": "019dd9e1-47ab-72ce-a079-aab1f5299e88", "version": 1, "bodyDocId": null, "description": "Translating a claim into numbers, charts, or tables.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": "primary", "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:37+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9cd6-df07fd2d3014", "parentComponentId": null }, { "bbox": { "h": 0.42, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "137 of the 612 cases are classified as serious adverse events of which we note one recent (2022) fatality (dizziness/heart attack two weeks after starting the drug and on the first day the dose was titrated to the max 35.6mg); 2 disabled (17 and 52-year old); 2 life-threatening; and 42 hospitalizations. Below we list the large number of serious adverse events which indicate cardiotoxicity – generally requiring hospitalization. We note that dizziness and seizures are among the most common symptoms of QT prolongation. Across both serious and non-serious event reports, we counted 29 that mentioned “dizziness.” Within serious adverse events specifically, per the list below, we note the frequency of events involving cardiac arrest, myocardial infarction, loss of consciousness, QT prolongation, atrial fibrillation, myocarditis, palpitations, vertigo, hypertension, and stroke.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:07.313+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "ebdfaa21-db5a-454a-b659-cae8c0e4d87b", "parentComponentId": null }, { "bbox": { "h": 0.03, "w": 0.6, "x": 0.07, "y": 0.96 }, "kind": "source-note", "text": "Source: Scorpion Capital analysis and estimates based on FDA FAERS database for Wakix; pitolisant; pitolisant hydrochloride", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. Numbered footnotes use attrs.numbered." }, "tool": null, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:07.313+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "3edb8324-d023-468e-bd19-bb5671c81a73", "parentComponentId": null } ], "metrics": [], "tools": [], "frameworks": [], "arcBeats": [], "loops": [], "locked": true }, { "page": 176, "type": "appendix", "title": "The slide highlights specific medical conditions and counts of adverse event reports from the FDA FAERS database.", "function": "analyze_data", "rawType": "other", "block": null, "metadata": { "slideType": "other", "slideTypeCanon": { "name": "Other (fallback)", "slug": "other", "status": "active", "canonId": "019de52d-0af5-71ed-83de-d51ae245fc43", "version": 1, "description": null }, "function": "analyze_data", "functionCanon": { "name": "Analyze data", "slug": "analyze_data", "status": "active", "canonId": "019de52d-1590-7413-8c82-cc218cff40b4", "version": 1, "description": null }, "density": "balanced", "densityScore": 41, "componentCount": 4, "textChars": 1235, "nDataPoints": 10, "notes": "The slide highlights specific medical conditions and counts of adverse event reports from the FDA FAERS database.", "elementsJson": [ "paragraph", "bullet_list", "footnote" ], "confidence": 0.9, "extraction": { "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "at": "2026-05-02 20:18:07.894+00", "seconds": 3.115, "promptVersion": "v2-canon-conditioned" } }, "links": { "slide": "/slides/019dd923-622c-750b-8b9a-21918ac10c17/176", "deck": "/decks/019dd923-622c-750b-8b9a-21918ac10c17", "deckAnchor": "/decks/019dd923-622c-750b-8b9a-21918ac10c17#slide-176", "deckJson": "/decks/019dd923-622c-750b-8b9a-21918ac10c17.json" }, "components": [ { "bbox": null, "kind": "callout", "text": "We speculate that the embolisms may be related to pitolisant’s phospholipidosis liability and/or its potential to cause hypereosinophilic syndrome.", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": { "name": "Visual emphasis", "slug": "visual-emphasis", "status": "active", "bestFor": null, "canonId": "019dd9e1-474b-736b-a8eb-a794dd88241c", "version": 1, "bodyDocId": null, "description": "Drawing the eye to one element above the rest of the slide.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:37+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9cd7-cdd5a6077d56", "parentComponentId": null }, { "bbox": { "h": 0.25, "w": 0.47, "x": 0.07, "y": 0.41 }, "kind": "list", "text": "Serious adverse event reports which contain the following symptoms or combinations of symptoms\nAcute kidney injury (1)\nHepatic enzyme elevation/pulmonary embolism (1)\nAbnormal hepatic function/pericarditis (1)\nHepatic cytolysis (2)\nAcute hepatitis (1)\nPulmonary embolism (4)", "attrs": null, "canon": { "kind": { "name": "List", "slug": "list", "status": "active", "canonId": "019de52c-f94b-779b-a53b-fd4904a5f4d2", "version": 1, "description": "Bullet or numbered list." }, "tool": null, "subkind": { "name": "Bullet list", "slug": "bullet", "status": "active", "canonId": "019de52c-fc98-7169-a083-5cab805076ca", "version": 1, "description": null }, "framework": null }, "subkind": "bullet", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:07.894+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "5feb3b33-98e3-4616-9d51-e936456f9799", "parentComponentId": null }, { "bbox": { "h": 0.35, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "In addition to serious adverse event reports with cardiac symptoms, we note reports of kidney, liver, or pulmonary-related events that were life-threatening and/or required hospitalization: acute kidney injury (42-year old hospitalized with kidney failure); hepatic enzyme elevation; abnormal hepatic function; two reports of hepatic cytolysis, both relatively young patients (37 and 45 years old); and acute hepatitis (18-year old). Pulmonary embolism is mentioned in four reports, and in a fifth in combination with hepatic enzyme elevation. 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For example, total revenue in 2019 and 2020 (almost all in 2020) was ~$165MM. Using an average drug price of $150K/year yields ~1,100 patient years on drug with 415 adverse events during that period. A similar estimate across 2021/2022 yields 4,800 patient years, about 4.5X higher, which would imply 1,900 adverse event reports. The 4.5X factor likely overstates the number, as 2019 included patients in the expanded access program who were presumably not counted as revenue, and some of the events occurred in Europe. Nonetheless, despite the imprecise methodology, it would be unusual for the number of case reports to fall sharply in 2021/2022 with patient counts spiking, suggesting the true figure is multiples higher. We see a similar falloff although not as drastic, regarding the 137 of the 602 adverse events that are classified as serious, indicating that those are too likely substantially higher. 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Numbered footnotes use attrs.numbered." }, "tool": null, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:08.463+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "220eecd9-a8e3-4fb6-8815-81bd81eb3cb8", "parentComponentId": null }, { "bbox": { "h": 0.06, "w": 0.9, "x": 0.07, "y": 0.1 }, "kind": "title", "text": "A 70-year old male experienced a heart attack and died two weeks after starting pitolisant – full case narrative below.", "attrs": null, "canon": { "kind": { "name": "Title", "slug": "title", "status": "active", "canonId": "019de52c-f7dd-76d9-b848-b1f12bd85cf4", "version": 1, "description": "Slide title or headline." }, "tool": null, "subkind": { "name": "Action title", "slug": "action-title", "status": "active", "canonId": "019de52c-fb31-734c-a0f5-a3935b73135d", "version": 1, "description": null }, "framework": null }, "subkind": "action-title", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:08.463+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "832a99b2-4c42-4917-a0aa-71a3f66c1e07", "parentComponentId": null }, { "bbox": { "h": 0.03, "w": 0.65, "x": 0.07, "y": 0.07 }, "kind": "title", "text": "Case ID: 21248927, Event date: July 26, 2022 (page 2/2)", "attrs": null, "canon": { "kind": { "name": "Title", "slug": "title", "status": "active", "canonId": "019de52c-f7dd-76d9-b848-b1f12bd85cf4", "version": 1, "description": "Slide title or headline." }, "tool": null, "subkind": { "name": "Headline", "slug": "headline", "status": "active", "canonId": "019de52c-fae1-7463-9a7c-d60668eced0d", "version": 1, "description": null }, "framework": null }, "subkind": "headline", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:08.463+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "e7441c58-3289-4724-80f7-85840ebe4a51", "parentComponentId": null } ], "metrics": [], "tools": [], "frameworks": [], "arcBeats": [], "loops": [], "locked": true }, { "page": 183, "type": "appendix", "title": "The slide presents a clinical case study narrative, likely for pharmacovigilance or safety analysis.", "function": "illustrate_case", "rawType": "other", "block": null, "metadata": { "slideType": "other", "slideTypeCanon": { "name": "Other (fallback)", "slug": "other", "status": "active", "canonId": "019de52d-0af5-71ed-83de-d51ae245fc43", "version": 1, "description": null }, "function": "illustrate_case", "functionCanon": { "name": "Illustrate case", "slug": "illustrate_case", "status": "active", "canonId": "019de52d-13b4-772c-bb73-1873612a7463", "version": 1, "description": null }, "density": "dense", "densityScore": 55, "componentCount": 7, "textChars": 1594, "nDataPoints": 0, "notes": "The slide presents a clinical case study narrative, likely for pharmacovigilance or safety analysis.", "elementsJson": [ "headline_text", "paragraph", "footnote" ], "confidence": 1, "extraction": { "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "at": "2026-05-02 20:18:12.878+00", "seconds": 6.664, "promptVersion": "v2-canon-conditioned" } }, "links": { "slide": "/slides/019dd923-622c-750b-8b9a-21918ac10c17/183", "deck": "/decks/019dd923-622c-750b-8b9a-21918ac10c17", "deckAnchor": "/decks/019dd923-622c-750b-8b9a-21918ac10c17#slide-183", "deckJson": "/decks/019dd923-622c-750b-8b9a-21918ac10c17.json" }, "components": [ { "bbox": null, "kind": "callout", "text": "A 57-year old male patient on 17.8mg of pitolisant experienced \"seizures and blacking out.\" Pitolisant was discontinued and the symptoms resolved.", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": { "name": "Visual emphasis", "slug": "visual-emphasis", "status": "active", "bestFor": null, "canonId": "019dd9e1-474b-736b-a8eb-a794dd88241c", "version": 1, "bodyDocId": null, "description": "Drawing the eye to one element above the rest of the slide.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:37+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9cd7-fd1e8594c494", "parentComponentId": null }, { "bbox": { "h": 0.09, "w": 0.86, "x": 0.07, "y": 0.11 }, "kind": "paragraph", "text": "A 57-year old male patient on 17.8mg of pitolisant experienced “seizures and blacking out.” Pitolisant was discontinued and the symptoms resolved. No other information is provided. We note that seizures and fainting are one of the main symptoms of QT prolongation.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:12.878+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "21d9cad9-a079-4559-ba22-bca67fa9be10", "parentComponentId": null }, { "bbox": { "h": 0.18, "w": 0.86, "x": 0.07, "y": 0.27 }, "kind": "paragraph", "text": "On 14-FEB-2020, a spontaneous report was received from a consumer, via a company representative (Case ID: 021420-2048717), regarding a 57-year-old male who was being treated with WAKIX 17.8 MG (pitolisant). On 09-MAY-2022, the Report Type for this case is being revised from spontaneous to solicited since the initial case information originated from a company-sponsored patient support program.# This case is therefore downgraded to Not Reportable in accordance with the applicable regulatory guidance. Medical history and concomitant products were not reported. On an unspecified date, the patient started treatment with WAKIX 17.8 MG at 17.8 mg, via an unreported route of administration, once daily for an unreported indication. On an unspecified date, after starting the product, the patient experienced seizures and blacking out; which the reporter noted \"were the same.\" As of 14-FEB-2020, treatment with WAKIX was discontinued and the seizures and blacking out were resolved. No additional information was provided. .", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:12.878+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "debe010f-8d06-4f3d-b508-613b917872c1", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "“seizures and blacking out.” — FDA FAERS Case Report", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:37+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9cd8-02adc4af3e21", "parentComponentId": null }, { "bbox": { "h": 0.02, "w": 0.3, "x": 0.07, "y": 0.95 }, "kind": "source-note", "text": "Source: FDA FAERS – FOIA Case Report Information", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. Numbered footnotes use attrs.numbered." }, "tool": null, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:12.878+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "82d83fbe-d7c6-49d0-bb4b-21a544c3a64d", "parentComponentId": null }, { "bbox": { "h": 0.03, "w": 0.45, "x": 0.07, "y": 0.07 }, "kind": "title", "text": "Case ID: 17861258, Event date: 2020", "attrs": null, "canon": { "kind": { "name": "Title", "slug": "title", "status": "active", "canonId": "019de52c-f7dd-76d9-b848-b1f12bd85cf4", "version": 1, "description": "Slide title or headline." }, "tool": null, "subkind": { "name": "Headline", "slug": "headline", "status": "active", "canonId": "019de52c-fae1-7463-9a7c-d60668eced0d", "version": 1, "description": null }, "framework": null }, "subkind": "headline", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:12.878+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "30a07421-066d-47c7-bec9-b3dd890fdd73", "parentComponentId": null }, { "bbox": { "h": 0.02, "w": 0.2, "x": 0.07, "y": 0.23 }, "kind": "title", "text": "Event/Problem Narrative:", "attrs": null, "canon": { "kind": { "name": "Title", "slug": "title", "status": "active", "canonId": "019de52c-f7dd-76d9-b848-b1f12bd85cf4", "version": 1, "description": "Slide title or headline." }, "tool": null, "subkind": { "name": "Subtitle", "slug": "subtitle", "status": "active", "canonId": "019de52c-fb09-739d-900c-815b0d9ac526", "version": 1, "description": null }, "framework": null }, "subkind": "subtitle", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:12.878+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "b52547f8-f72c-493f-a849-3ca082404309", "parentComponentId": null } ], "metrics": [], "tools": [], "frameworks": [], "arcBeats": [], "loops": [], "locked": true }, { "page": 184, "type": "appendix", "title": "The slide highlights a potential cover-up or reporting discrepancy regarding a patient seizure.", "function": "expose_contradiction", "rawType": "other", "block": null, "metadata": { "slideType": "other", "slideTypeCanon": { "name": "Other (fallback)", "slug": "other", "status": "active", "canonId": "019de52d-0af5-71ed-83de-d51ae245fc43", "version": 1, "description": null }, "function": "expose_contradiction", "functionCanon": { "name": "Expose contradiction", "slug": "expose_contradiction", "status": "active", "canonId": "019de52d-171f-776f-887c-73edaff4cf9c", "version": 1, "description": null }, "density": "balanced", "densityScore": 48, "componentCount": 6, "textChars": 1637, "nDataPoints": 0, "notes": "The slide highlights a potential cover-up or reporting discrepancy regarding a patient seizure.", "elementsJson": [ "paragraph", "callout_box", "footnote" ], "confidence": 0.9, "extraction": { "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "at": "2026-05-02 20:18:09.536+00", "seconds": 3.029, "promptVersion": "v2-canon-conditioned" } }, "links": { "slide": "/slides/019dd923-622c-750b-8b9a-21918ac10c17/184", "deck": "/decks/019dd923-622c-750b-8b9a-21918ac10c17", "deckAnchor": "/decks/019dd923-622c-750b-8b9a-21918ac10c17#slide-184", "deckJson": "/decks/019dd923-622c-750b-8b9a-21918ac10c17.json" }, "components": [ { "bbox": null, "kind": "callout", "text": "The case report suggests a potential attempt by the physician’s office to cover up the event.", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": { "name": "Visual emphasis", "slug": "visual-emphasis", "status": "active", "bestFor": null, "canonId": "019dd9e1-474b-736b-a8eb-a794dd88241c", "version": 1, "bodyDocId": null, "description": "Drawing the eye to one element above the rest of the slide.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:38+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9cd8-663e2a77111c", "parentComponentId": null }, { "bbox": { "h": 0.25, "w": 0.86, "x": 0.07, "y": 0.11 }, "kind": "paragraph", "text": "A male patient of unreported age, on an unreported date after starting pitolisant, “experienced a seizure and treatment with Wakix and ‘all medicine’ was withdrawn.” The case report suggests a potential attempt by the physician’s office to cover up the event. On Jan 30, 2020, an adverse event report was provided by a nurse via company representative. On Feb 30, 2020, additional info was received from “an anonymous non healthcare provider.” On the same date, the physician’s office reported that “the seizure, occurring after starting the product, was ‘not true’ and ‘an error.’”", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:09.536+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "185f122f-0c09-4e03-8dff-a02c3b6bfdce", "parentComponentId": null }, { "bbox": { "h": 0.15, "w": 0.86, "x": 0.07, "y": 0.43 }, "kind": "paragraph", "text": "Event/Problem Narrative: On 30-JAN-2020, a spontaneous report was received from a nurse, via a company representative, regarding a male of an unreported age who was being treated with WAKIX (pitolisant). On 13-FEB-2020, additional information was received from an anonymous non healthcare provider. Medical history included narcolepsy and seizures. Concomitant products were not reported. On an unspecified date, after starting the product, the patient experienced a seizure and treatment with WAKIX and \"all medicine\" was withdrawn. As of 30-JAN-2020, the status of the seizure was not reported. 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Lab tests for viral causes were negative, suggesting it may be drug-induced. The report notes the lack of info regarding dose, baseline hepatic function, clinical course, or outcome. Nor does it state if the patient was hospitalized. The patient had a complex medical history including “chronic kidney failure,” dialysis, diabetes, pancreatic failure, and narcolepsy. The pitolisant label suggests 17.8mg daily for patients with moderate or severe renal impairment, although the full prescribing information contains a PK chart that shows 5-fold higher plasma levels in patients with severe impairment at the 90% confidence interval. The patient’s medical history is hardly unusual for narcolepsy patients who present with myriad comorbidities such as obesity, diabetes, cardiovascular history, etc. The report notes that the physician thought it was unrelated to pitolisant and continued treatment, while the FDA stated that “based on a temporal association, a contributory role of WAKIX cannot be ruled out.”", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:10.036+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "b629dfdf-1711-4863-a560-e7a44986930d", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "“based on a temporal association, a contributory role of WAKIX cannot be ruled out.” — FDA", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:39+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9cd8-e50b8c6fe94a", "parentComponentId": null }, { "bbox": { "h": 0.02, "w": 0.3, "x": 0.07, "y": 0.96 }, "kind": "source-note", "text": "Source: FDA FAERS – FOIA Case Report Information", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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Pitolisant was discontinued and the embolism resolved within 13 days. Patient was concomitantly on fluvoxamine, an SSRI which is a potent CYP2D6 inhibitor. As we note in a previous section, drug-drug interactions with CYP2D6 inhibitors can lead plasma levels of pitolisant to spike.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:10.391+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "401ec037-30ed-4487-b271-b165f1b413e8", "parentComponentId": null }, { "bbox": { "h": 0.2, "w": 0.86, "x": 0.07, "y": 0.68 }, "kind": "paragraph", "text": "Case ID: 21370166. First dose of aripiprazole and 15 days after the first dose of Wakix, the patient experienced pulmonary embolism...", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:10.391+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "4642669a-0960-4065-8665-b100f5f6ba08", "parentComponentId": null }, { "bbox": { "h": 0.1, "w": 0.86, "x": 0.07, "y": 0.28 }, "kind": "paragraph", "text": "Event/Problem Narrative: This initial spontaneous report was reported by the health authority European Medicines Agency (EMA)...", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:10.391+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "742aeee3-1f7c-49a9-8499-b71146a11cfe", "parentComponentId": null }, { "bbox": { "h": 0.02, "w": 0.3, "x": 0.07, "y": 0.95 }, "kind": "source-note", "text": "Source: FDA FAERS – FOIA Case Report Information", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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Lab tests revealed “elevated liver enzymes” and “elevated bilirubin of unknown etiology” – “however, it was determined that the patient did not have any type of infection.” The patient was discharged and hospitalized again a day later. A CT scan revealed “two pulmonary emboli in the right lower lobe of his lung.” The report suggests that the patient believed that the emboli were associated with pitolisant but that “nobody” believed him. Event was assessed as not related to pitolisant – case report doesn’t provide the rationale.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:11.946+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "5eb57ea1-72d6-4547-8588-b6394d3022f4", "parentComponentId": null }, { "bbox": { "h": 0.48, "w": 0.86, "x": 0.07, "y": 0.41 }, "kind": "paragraph", "text": "Event/Problem Narrative: On 01-OCT-2021 and 07-OCT-2021, a spontaneous report and follow-up information were received from a consumer describing a 71-year-old male who was being treated with WAKIX (pitolisant). Medical history and concomitant medications were not provided. On (b)(6)*****, after starting WAKIX and during the second week of titration (dose was 17.8 mg/day at the time), the patient went to the Emergency Room (ER) with complaints of fever of 103.9 degrees Fahrenheit (F), two bouts of explosive diarrhea and chills. The patient was subsequently admitted for further work-up. Laboratory results revealed elevated liver enzymes and bilirubin (values were not provided). Treatment was not provided; however, it was determined that the patient did not have any type of infection. The cause of the elevated liver enzymes and bilirubin were not provided. The patient was discharged to home on (b)(6)*****. He reported that he did not receive WAKIX while in the hospital and denied any withdrawal symptoms. On (b)(6)*****, the patient returned to the ER with complaints of fever, chills, severe back pain and bilateral flank pain. A Computed Tomography (CT) scan revealed two pulmonary emboli in the right lower lobe of his lung. The patient was readmitted to the hospital and treatment with Eliquis (apixaban) was initiated (dose/frequency not provided). The patient reported that \"nobody\" (presumed to mean those involved in his care) believed the pulmonary emboli were associated with WAKIX. On (b)(6)*****, treatment with WAKIX was resumed at 35.6 mg, 1x/day. On(b)(6)*****, the patient was discharged to home. On 07-OCT-2021, the patient reported he was feeling better and improving. Follow-up information has been requested. Sponsor's Assessment: A 71-year-old male, treated with WAKIX, was hospitalized for a high fever, diarrhea, chills, elevated liver enzymes, and elevated bilirubin of unknown etiology, as infectious etiology was ruled out. The patient was readmitted one day following discharge with severe back pain and bilateral flank pain, at which time a diagnosis of pulmonary emboli was made. Following discharge after his readmission, the events were reported as improving while treatment with WAKIX was resumed. Although precluded by a lack of information regarding medical history and concomitant medication usage, the pulmonary emboli, fever, diarrhea, chills, elevated liver enzymes, elevated bilirubin, and flank and back pain were assessed as not related to WAKIX.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:11.946+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "82fadd23-7c27-4a58-9eff-9d42b27514b5", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "The report suggests that the patient believed that the emboli were associated with pitolisant but that \"nobody\" believed him.", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:51+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d1-73a9-abba-b466d4716469", "parentComponentId": null }, { "bbox": { "h": 0.02, "w": 0.3, "x": 0.07, "y": 0.95 }, "kind": "source-note", "text": "Source: FDA FAERS – FOIA Case Report Information", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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After 11 days on drug, patient was hospitalized for mania, psychotic disorder, bipolar disorder, and insomnia. Patient was also on Wellbutrin, a potent CYP2D6 inhibitor, which we suspect may have spiked plasma levels of pitolisant. Patient may have been on half the maximal dose due to potential drug-drug interaction with Wellbutrin, per suggestion on the label, but still ended up in the hospital. 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Numbered footnotes use attrs.numbered." }, "tool": null, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:10.681+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "7e23beeb-a4bf-48fe-834f-007ca101ca9f", "parentComponentId": null }, { "bbox": { "h": 0.03, "w": 0.45, "x": 0.07, "y": 0.07 }, "kind": "title", "text": "Case ID: 17241759, event date: Dec 2019", "attrs": null, "canon": { "kind": { "name": "Title", "slug": "title", "status": "active", "canonId": "019de52c-f7dd-76d9-b848-b1f12bd85cf4", "version": 1, "description": "Slide title or headline." }, "tool": null, "subkind": { "name": "Headline", "slug": "headline", "status": "active", "canonId": "019de52c-fae1-7463-9a7c-d60668eced0d", "version": 1, "description": null }, "framework": null }, "subkind": "headline", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:10.681+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "25730408-2535-4ff0-9873-4e49a06620fd", "parentComponentId": null } ], "metrics": [], "tools": [], "frameworks": [], "arcBeats": [], "loops": [], "locked": true }, { "page": 193, "type": "tension", "title": "The slide uses a narrative structure to expose a potential cover-up or reporting failure regarding a serious adverse event.", "function": "expose_contradiction", "rawType": "expose_contradiction", "block": null, "metadata": { "slideType": "expose_contradiction", "slideTypeCanon": { "name": "Expose contradiction", "slug": "expose_contradiction", "status": "active", "canonId": "019de52d-124c-75aa-984a-0a3d0d8fc8df", "version": 1, "description": null }, "function": "expose_contradiction", "functionCanon": { "name": "Expose contradiction", "slug": "expose_contradiction", "status": "active", "canonId": "019de52d-171f-776f-887c-73edaff4cf9c", "version": 1, "description": null }, "density": "dense", "densityScore": 57, "componentCount": 6, "textChars": 4437, "nDataPoints": 0, "notes": "The slide uses a narrative structure to expose a potential cover-up or reporting failure regarding a serious adverse event.", "elementsJson": [ "paragraph", "footnote" ], "confidence": 1, "extraction": { "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "at": "2026-05-02 20:18:12.092+00", "seconds": 4.251, "promptVersion": "v2-canon-conditioned" } }, "links": { "slide": "/slides/019dd923-622c-750b-8b9a-21918ac10c17/193", "deck": "/decks/019dd923-622c-750b-8b9a-21918ac10c17", "deckAnchor": "/decks/019dd923-622c-750b-8b9a-21918ac10c17#slide-193", "deckJson": "/decks/019dd923-622c-750b-8b9a-21918ac10c17.json" }, "components": [ { "bbox": null, "kind": "callout", "text": "The sequence of events suggests a potential attempt to conceal the severity of the event, as the initial adverse event report by the physician and company did not appear to mention the patient was hospitalized.", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": { "name": "Visual emphasis", "slug": "visual-emphasis", "status": "active", "bestFor": null, "canonId": "019dd9e1-474b-736b-a8eb-a794dd88241c", "version": 1, "bodyDocId": null, "description": "Drawing the eye to one element above the rest of the slide.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:39+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d1-73a9-abb4-7b95d7983a16", "parentComponentId": null }, { "bbox": { "h": 0.35, "w": 0.86, "x": 0.07, "y": 0.11 }, "kind": "paragraph", "text": "17 year old female patient on 17.8mg. Four to five weeks after starting pitolisant, patient was hospitalized for a disassociative/bipolar state with anxiety. Patient was treated with risperdone, an anti-psychotic medication. Symptoms persisted for a week after pitolisant was terminated. “Based on the temporal relationship, the known risk of anxiety and bipolar disorder associated with WAKIX, and the improvement of symptoms following discontinuation, a causal association with WAKIX cannot be ruled out.” The sequence of events suggests a potential attempt to conceal the severity of the event, as the initial adverse event report by the physician and company did not appear to mention the patient was hospitalized. However, the patient’s mother “reported that her daughter was in the hospital due to side effects of the medication,” and the physician then confirmed that this was the same patient as “it was not known at the time [of the mother’s report] that this patient was the same case reported by the physician.”", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:12.092+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "0fc861a8-ff9b-4f98-b887-7bd3d08c0500", "parentComponentId": null }, { "bbox": { "h": 0.35, "w": 0.86, "x": 0.07, "y": 0.59 }, "kind": "paragraph", "text": "Event/Problem Narrative: On 30-MAR-2021, a spontaneous report was received from a physician regarding a 17-year-old female who was treated with WAKIX (pitolisant). On 06-APR-2021, additional information was received from the patient#s mother via a company representative, and based on the information, the case was assessed as serious and unexpected. On 13-APR-2021, additional information was received from the physician. Medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient started treatment with WAKIX for the treatment of narcolepsy with cataplexy. The physician reported that 4 to 5 weeks after starting WAKIX, the patient developed either an anxiety episode which was #new for her,# or what appeared to be a possible dissociation/bipolar-like state. The reporting physician noted that alternatively, since she had a positive response to WAKIX, that a mood disorder state is emerging more obviously with improved energy and less excessive daytime sleepiness. As of 30-MAR-2021, the action taken with WAKIX, and the outcome of the anxiety, dissociation, bipolar-like state, and mood disorder were not reported. No additional information was reported. On (b)(6)*****, a patient#s mother reported that her daughter was in the hospital due to #side effects# of the medication (presumed to be WAKIX 17.8 mg once daily). It was not known at the time that this patient was the same case reported by the physician on 30-MAR-2021. On 13-APR-2021, the physician confirmed this was the same patient. The physician reported that treatment with WAKIX was withdrawn on an unspecified date and the symptoms persisted for more than one week after discontinuing WAKIX. The patient#s symptoms stabilized with treatment, which included risperidone. She was discharged from hospital during the weekend of (b)(6)********. As of 13-APR-2021, the outcome of the events was reported as improved. No additional information was reported. Comment: Four to five weeks after the start of WAKIX for the treatment of narcolepsy with cataplexy, a 17-year-old female developed either an anxiety episode, possible dissociation/bipolar-like state, or symptoms of a mood disorder for which she was hospitalized. The symptoms persisted for more than one week after WAKIX was discontinued but stabilized with treatment, which included risperidone. As of the last report, the patient had been discharged from the hospital and the outcome of the events was reported as improved. Based on the temporal relationship, the known risk of anxiety and bipolar disorder associated with WAKIX, and the improvement of symptoms following discontinuation, a causal association with WAKIX cannot be ruled out. The patient also received treatment with an antipsychotic following WAKIX discontinuation, likely contributing to the improvement in her symptoms.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:12.092+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "1e12ecd4-57a5-44aa-9419-3f4b4af8174b", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "Based on the temporal relationship, the known risk of anxiety and bipolar disorder associated with WAKIX, and the improvement of symptoms following discontinuation, a causal association with WAKIX cannot be ruled out. — FDA FAERS – FOIA Case Report Information", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:39+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d1-73a9-abb4-7eafc886bddd", "parentComponentId": null }, { "bbox": { "h": 0.02, "w": 0.25, "x": 0.07, "y": 0.95 }, "kind": "source-note", "text": "Source: FDA FAERS – FOIA Case Report Information", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. Numbered footnotes use attrs.numbered." }, "tool": null, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:12.092+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "33a64845-14f9-40f0-8d83-2b1b1ee63713", "parentComponentId": null }, { "bbox": { "h": 0.03, "w": 0.45, "x": 0.07, "y": 0.07 }, "kind": "title", "text": "Case ID: 19164134, Event date: 2021", "attrs": null, "canon": { "kind": { "name": "Title", "slug": "title", "status": "active", "canonId": "019de52c-f7dd-76d9-b848-b1f12bd85cf4", "version": 1, "description": "Slide title or headline." }, "tool": null, "subkind": { "name": "Headline", "slug": "headline", "status": "active", "canonId": "019de52c-fae1-7463-9a7c-d60668eced0d", "version": 1, "description": null }, "framework": null }, "subkind": "headline", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:12.092+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "d49067a4-ede6-493e-bd54-e908790f580e", "parentComponentId": null } ], "metrics": [], "tools": [], "frameworks": [], "arcBeats": [], "loops": [], "locked": true }, { "page": 194, "type": "appendix", "title": "This is a medical case report summary, likely used for pharmacovigilance or safety analysis.", "function": "illustrate_case", "rawType": "other", "block": null, "metadata": { "slideType": "other", "slideTypeCanon": { "name": "Other (fallback)", "slug": "other", "status": "active", "canonId": "019de52d-0af5-71ed-83de-d51ae245fc43", "version": 1, "description": null }, "function": "illustrate_case", "functionCanon": { "name": "Illustrate case", "slug": "illustrate_case", "status": "active", "canonId": "019de52d-13b4-772c-bb73-1873612a7463", "version": 1, "description": null }, "density": "dense", "densityScore": 55, "componentCount": 6, "textChars": 3264, "nDataPoints": 0, "notes": "This is a medical case report summary, likely used for pharmacovigilance or safety analysis.", "elementsJson": [ "paragraph", "footnote" ], "confidence": 1, "extraction": { "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "at": "2026-05-02 20:18:16.989+00", "seconds": 8.936, "promptVersion": "v2-canon-conditioned" } }, "links": { "slide": "/slides/019dd923-622c-750b-8b9a-21918ac10c17/194", "deck": "/decks/019dd923-622c-750b-8b9a-21918ac10c17", "deckAnchor": "/decks/019dd923-622c-750b-8b9a-21918ac10c17#slide-194", "deckJson": "/decks/019dd923-622c-750b-8b9a-21918ac10c17.json" }, "components": [ { "bbox": null, "kind": "callout", "text": "The report noted that \"with a positive dechallenge, a causal association with WAKIX for the events cannot be ruled out.\"", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": { "name": "Visual emphasis", "slug": "visual-emphasis", "status": "active", "bestFor": null, "canonId": "019dd9e1-474b-736b-a8eb-a794dd88241c", "version": 1, "bodyDocId": null, "description": "Drawing the eye to one element above the rest of the slide.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:52+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d1-73a9-abbb-7af2ec343314", "parentComponentId": null }, { "bbox": { "h": 0.38, "w": 0.86, "x": 0.07, "y": 0.48 }, "kind": "paragraph", "text": "Event/Problem Narrative: On 11-JUN-2020, a spontaneous report was received from a nurse practitioner via a company representative regarding a 45-year-old male who was being treated with WAKIX (pitolisant). On 20-JUL-2020, additional information was received from a nurse practitioner. Medical history included bipolar disorder, depression, anxiety, and visits to the psychiatric ED (emergency department; last in 2017). Concomitant products were not reported. On an unspecified date in 2020 (reported as (b)(6)************ relative to (b)(6)*****), the patient started treatment with WAKIX for narcolepsy. On(b)(6)******, around the time WAKIX was titrated to the maximum dose of 35.6 mg once daily (also reported as \"when he got up to the full dose\"), the patient had a manic episode and went to a psychiatric hospital ER (emergency department), and required inpatient hospitalization for approximately (b)(6) weeks. While hospitalized, the patient was diagnosed with paranoid schizophrenia and was started on Latuda (lurasidone hydrochloride). The patient also felt sad, was screaming, very aggressive, and said he felt like he was God. On an unspecified date (reported as \"recently\" relative to(b)(6)******), the patient was discharged to home. The patient was taken off WAKIX and subsequently felt \"fine\" which was presumed to mean manic episode, aggression, screaming, and sad feeling were resolved. As of 11-JUN-2020, the event of paranoid schizophrenia was ongoing. No additional information was provided. On 20-JUL-2020, the nurse practitioner reported that the patient was Caucasian and that there was a big lag time between when she prescribed the product and when the patient started it. No additional information was provided. Comment: A 45-year-old male, with a history of bipolar disorder, treated with WAKIX for narcolepsy, experienced a manic episode requiring inpatient hospitalization. While hospitalized, he was diagnosed with paranoid schizophrenia. WAKIX was discontinued, and subsequently he felt \"fine.\" Paranoid schizophrenia was ongoing. With a positive dechallenge, a causal association with WAKIX for the events cannot be ruled out.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:16.989+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "10d03663-e5ed-465e-8aa8-e45d244e237a", "parentComponentId": null }, { "bbox": { "h": 0.32, "w": 0.86, "x": 0.07, "y": 0.11 }, "kind": "paragraph", "text": "A 45-year old male patient, “around the time WAKIX was titrated to the maximum dose of 35.6 mg once daily (also reported as \"when he got up to the full dose\"), the patient had a manic episode and went to a psychiatric hospital ER (emergency room), and required inpatient hospitalization for approximately (b)(6) weeks.” The patient also “felt sad, was screaming, very aggressive, and said he felt like he was God.” Patient was also diagnosed with paranoid schizophrenia while in the hospital. Pitolisant was discontinued and the patient “subsequently felt ‘fine’ which was presumed to mean manic episode, aggression, screaming, and sad feeling were resolved.” The report noted that “with a positive dechallenge, a causal association with WAKIX for the events cannot be ruled out.”", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:16.989+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "202a6980-66fd-412e-a157-f1bb04612f04", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "\"with a positive dechallenge, a causal association with WAKIX for the events cannot be ruled out.\" — FDA FAERS Case Report", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:52+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d1-73a9-abbb-7e6ac2927e06", "parentComponentId": null }, { "bbox": { "h": 0.02, "w": 0.3, "x": 0.07, "y": 0.95 }, "kind": "source-note", "text": "Source: FDA FAERS – FOIA Case Report Information", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. Numbered footnotes use attrs.numbered." }, "tool": null, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:16.989+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "325f2c82-992d-445e-b46f-5c62a3e3bb1e", "parentComponentId": null }, { "bbox": { "h": 0.03, "w": 0.45, "x": 0.07, "y": 0.07 }, "kind": "title", "text": "Case ID: 17930672, Event date: 2020", "attrs": null, "canon": { "kind": { "name": "Title", "slug": "title", "status": "active", "canonId": "019de52c-f7dd-76d9-b848-b1f12bd85cf4", "version": 1, "description": "Slide title or headline." }, "tool": null, "subkind": { "name": "Headline", "slug": "headline", "status": "active", "canonId": "019de52c-fae1-7463-9a7c-d60668eced0d", "version": 1, "description": null }, "framework": null }, "subkind": "headline", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:16.989+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "752ac808-c990-45bf-b132-480bdb7d5fba", "parentComponentId": null } ], "metrics": [], "tools": [], "frameworks": [], "arcBeats": [], "loops": [], "locked": true }, { "page": 195, "type": "appendix", "title": "This is a pharmacovigilance case report summary.", "function": "diagnose_problem", "rawType": "other", "block": null, "metadata": { "slideType": "other", "slideTypeCanon": { "name": "Other (fallback)", "slug": "other", "status": "active", "canonId": "019de52d-0af5-71ed-83de-d51ae245fc43", "version": 1, "description": null }, "function": "diagnose_problem", "functionCanon": { "name": "Diagnose problem", "slug": "diagnose_problem", "status": "active", "canonId": "019de52d-176d-761f-b608-cf52262d2ab2", "version": 1, "description": null }, "density": "dense", "densityScore": 50, "componentCount": 6, "textChars": 1844, "nDataPoints": 0, "notes": "This is a pharmacovigilance case report summary.", "elementsJson": [ "paragraph", "footnote" ], "confidence": 1, "extraction": { "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "at": "2026-05-02 20:18:10.875+00", "seconds": 2.702, "promptVersion": "v2-canon-conditioned" } }, "links": { "slide": "/slides/019dd923-622c-750b-8b9a-21918ac10c17/195", "deck": "/decks/019dd923-622c-750b-8b9a-21918ac10c17", "deckAnchor": "/decks/019dd923-622c-750b-8b9a-21918ac10c17#slide-195", "deckJson": "/decks/019dd923-622c-750b-8b9a-21918ac10c17.json" }, "components": [ { "bbox": null, "kind": "callout", "text": "Given the known risk of psychiatric events including bipolar disorder and depression, an association with WAKIX cannot be ruled out.", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": { "name": "Visual emphasis", "slug": "visual-emphasis", "status": "active", "bestFor": null, "canonId": "019dd9e1-474b-736b-a8eb-a794dd88241c", "version": 1, "bodyDocId": null, "description": "Drawing the eye to one element above the rest of the slide.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:40+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d1-73a9-abb4-e947db4de3dd", "parentComponentId": null }, { "bbox": { "h": 0.35, "w": 0.86, "x": 0.07, "y": 0.35 }, "kind": "paragraph", "text": "Event/Problem Narrative:\nOn 30-JUL-2020, a spontaneous report was received from a nurse practitioner via a company representative regarding a female in her mid-30s who was being treated with WAKIX (pitolisant). Medical history and concomitant products were not reported. On an unreported date, the patient started treatment with WAKIX for an unreported indication. On an unspecified date, the patient showed signs of psychosis. As of 30-JUL-2020, the status of treatment with WAKIX and outcome of signs of psychosis were not reported. No additional information was provided. Comment: A female patient in her mid-30s treated with WAKIX (pitolisant) for an unknown duration and indication showed signs of psychosis, not further described. Lack of further information, including medical history, psychiatric history, concomitant medications, treatment duration, and event details, precludes a complete assessment. Given the known risk of psychiatric events including bipolar disorder and depression, an association with WAKIX cannot be ruled out. Follow-up information is being pursued.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:10.875+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "35c95b05-93fd-41bd-a905-921dd1789dd1", "parentComponentId": null }, { "bbox": { "h": 0.15, "w": 0.86, "x": 0.07, "y": 0.1 }, "kind": "paragraph", "text": "A female patient in her mid-30's who was being treated with an unknown dose of pitolisant “showed signs of psychosis.” No information was provided as to hospitalization, outcome, time to onset after starting pitolisant. “Given the known risk of psychiatric events including bipolar disorder and depression, an association with WAKIX cannot be ruled out. Follow-up information is being pursued.”", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:10.875+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "a4b992c1-63dd-4ad3-8f5e-347e5ae155a4", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "A female patient in her mid-30’s who was being treated with an unknown dose of pitolisant “showed signs of psychosis.” — FDA FAERS Case Report", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:40+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d1-73a9-abb4-ecaaa8c05506", "parentComponentId": null }, { "bbox": { "h": 0.02, "w": 0.3, "x": 0.07, "y": 0.95 }, "kind": "source-note", "text": "Source: FDA FAERS – FOIA Case Report Information", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. Numbered footnotes use attrs.numbered." }, "tool": null, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:10.875+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "683b50f9-6ddb-4051-8ecb-e8f9ff22ebe7", "parentComponentId": null }, { "bbox": { "h": 0.03, "w": 0.55, "x": 0.07, "y": 0.07 }, "kind": "title", "text": "Case ID: 18135725, Event date: 2020 (unclear)", "attrs": null, "canon": { "kind": { "name": "Title", "slug": "title", "status": "active", "canonId": "019de52c-f7dd-76d9-b848-b1f12bd85cf4", "version": 1, "description": "Slide title or headline." }, "tool": null, "subkind": { "name": "Headline", "slug": "headline", "status": "active", "canonId": "019de52c-fae1-7463-9a7c-d60668eced0d", "version": 1, "description": null }, "framework": null }, "subkind": "headline", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:10.875+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "fb1b4684-4578-47ec-b1dc-710751eb2ad9", "parentComponentId": null } ], "metrics": [], "tools": [], "frameworks": [], "arcBeats": [], "loops": [], "locked": true }, { "page": 196, "type": "appendix", "title": "The slide presents a specific pharmacovigilance case report, highlighting a positive dechallenge.", "function": "illustrate_case", "rawType": "other", "block": null, "metadata": { "slideType": "other", "slideTypeCanon": { "name": "Other (fallback)", "slug": "other", "status": "active", "canonId": "019de52d-0af5-71ed-83de-d51ae245fc43", "version": 1, "description": null }, "function": "illustrate_case", "functionCanon": { "name": "Illustrate case", "slug": "illustrate_case", "status": "active", "canonId": "019de52d-13b4-772c-bb73-1873612a7463", "version": 1, "description": null }, "density": "dense", "densityScore": 60, "componentCount": 7, "textChars": 2191, "nDataPoints": 0, "notes": "The slide presents a specific pharmacovigilance case report, highlighting a positive dechallenge.", "elementsJson": [ "paragraph", "footnote" ], "confidence": 1, "extraction": { "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "at": "2026-05-02 20:18:11.909+00", "seconds": 3.15, "promptVersion": "v2-canon-conditioned" } }, "links": { "slide": "/slides/019dd923-622c-750b-8b9a-21918ac10c17/196", "deck": "/decks/019dd923-622c-750b-8b9a-21918ac10c17", "deckAnchor": "/decks/019dd923-622c-750b-8b9a-21918ac10c17#slide-196", "deckJson": "/decks/019dd923-622c-750b-8b9a-21918ac10c17.json" }, "components": [ { "bbox": null, "kind": "callout", "text": "With a positive dechallenge, the events of psychiatric issues, aggression, and hallucinations are assessed as possibly related to WAKIX.", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": { "name": "Visual emphasis", "slug": "visual-emphasis", "status": "active", "bestFor": null, "canonId": "019dd9e1-474b-736b-a8eb-a794dd88241c", "version": 1, "bodyDocId": null, "description": "Drawing the eye to one element above the rest of the slide.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:39+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9cd8-c85410f0fe5f", "parentComponentId": null }, { "bbox": { "h": 0.25, "w": 0.86, "x": 0.07, "y": 0.31 }, "kind": "paragraph", "text": "On 07-OCT-2020, a spontaneous report was received from a physician regarding a female patient (age not reported) who was being treated with WAKIX (pitolisant). Medical history and concomitant medications were not reported. On an unspecified date, the patient started treatment with WAKIX for daytime sleepiness associated with narcolepsy. On an unreported date after starting WAKIX, the patient experienced \"psychiatric issues\" for which she was hospitalized. According to the reporter, the police were called since the patient became violent and was hallucinating. The patient was also COVID positive during this time. WAKIX was withdrawn. Following WAKIX discontinuation she was \"back to normal,\" presumed to mean psychiatric issues, violence, and hallucinations resolved. As of(b)(6)******, the patient's COVID status and the status of her hospitalization were not reported. No additional information was provided. Comment: A female patient was hospitalized for \"psychiatric issues,\" aggression and hallucinations while receiving WAKIX. The patient was also COVID positive during this time. After WAKIX was withdrawn, she recovered. With a positive dechallenge, the events of psychiatric issues, aggression, and hallucinations are assessed as possibly related to WAKIX. COVID positive test result is assessed as unrelated to WAKIX.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:11.909+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "281949f9-9bb9-40a1-98ab-15af5d7b96dd", "parentComponentId": null }, { "bbox": { "h": 0.15, "w": 0.86, "x": 0.07, "y": 0.11 }, "kind": "paragraph", "text": "A female patient of unknown age was “hospitalized for ‘psychiatric issues,’ aggression and hallucinations while receiving WAKIX.” According to the physician who submitted the report, “the police were called since the patient became violent and was hallucinating.” Pitolisant was withdrawn and the patient was “back to normal.” The patient was also COVID-positive. “With a positive dechallenge, the events of psychiatric issues, aggression, and hallucinations are assessed as possibly related to WAKIX.”", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:11.909+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "f6ce5da1-19e0-4bbb-b4e3-fb08d588e0fe", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "“hospitalized for ‘psychiatric issues,’ aggression and hallucinations while receiving WAKIX.” — Physician report", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:39+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d0-7099-9cd8-cecf658e4c1e", "parentComponentId": null }, { "bbox": { "h": 0.02, "w": 0.25, "x": 0.07, "y": 0.95 }, "kind": "source-note", "text": "Source: FDA FAERS – FOIA Case Report Information", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. Numbered footnotes use attrs.numbered." }, "tool": null, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:11.909+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "c3c59138-50fa-48e1-a6eb-30d55ffc043e", "parentComponentId": null }, { "bbox": { "h": 0.03, "w": 0.45, "x": 0.07, "y": 0.07 }, "kind": "title", "text": "Case ID: 18410926, Event date: 2020", "attrs": null, "canon": { "kind": { "name": "Title", "slug": "title", "status": "active", "canonId": "019de52c-f7dd-76d9-b848-b1f12bd85cf4", "version": 1, "description": "Slide title or headline." }, "tool": null, "subkind": { "name": "Headline", "slug": "headline", "status": "active", "canonId": "019de52c-fae1-7463-9a7c-d60668eced0d", "version": 1, "description": null }, "framework": null }, "subkind": "headline", "groupRole": null, "confidence": null, "extraction": { 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prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:12.431+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "368186d6-369c-413b-8fd1-94532ce86040", "parentComponentId": null }, { "bbox": { "h": 0.18, "w": 0.86, "x": 0.07, "y": 0.11 }, "kind": "paragraph", "text": "A female patient of an unknown age and on an unknown dose of pitolisant underwent an allergy skin test consisting of injections in a grid-like pattern on her back and arm. While the skin test was being performed, the patient experienced an anaphylactic reaction that required two EpiPens (epinephrine injections). “The reporting physician noted the reaction was uncharacteristic of allergy skin testing and implicated WAKIX due to its histaminergic activity. As hypersensitivity, including anaphylactic reaction, is a known risk associated with WAKIX, a causal or contributory role of WAKIX cannot be ruled out.”", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:12.431+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "e2b2b6c7-b2c2-4d8d-abfc-c70c97106a2b", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "The reporting physician noted the reaction was uncharacteristic of allergy skin testing and implicated WAKIX due to its histaminergic activity. As hypersensitivity, including anaphylactic reaction, is a known risk associated with WAKIX, a causal or contributory role of WAKIX cannot be ruled out. — FDA Adverse Event Reporting System (FAERS) FOIA Case Report", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:40+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d1-73a9-abb5-40f641638760", "parentComponentId": null }, { "bbox": { "h": 0.02, "w": 0.3, "x": 0.07, "y": 0.95 }, "kind": "source-note", "text": "Source: FDA FAERS – FOIA Case Report Information", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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On 13-MAR-2020, additional information was received from a consumer via a company representative (Case ID: 031320-R112068) and the case was re-assessed as serious and unexpected. On 06-MAY-2022, the Report Type for this case is being revised from spontaneous to solicited since the initial case information originated from a company-sponsored patient support program. This case has been assessed as serious, unexpected, and possibly related to WAKIX. Medical history included bipolar disorder, an underlying connective tissue disorder, and migraines. Concomitant products were not reported. On 03-MAR-2020, the patient started treatment with WAKIX. The doses, route(s) and frequencies of administration, and indication(s) of usage were not reported. On an unspecified date(s) in MAR-2020, after starting the product, the patient experienced major anxiety, problems with her mood, mania, musculoskeletal pain, and joint pain. Additionally, since starting therapy, the patient noticed an increase in the severity of her migraines. On an unspecified date in (b)(6)** (\"recently\" relative to (b)(6)*****), the patient started having an anaphylactic reaction. The symptoms were described as swelling and burning of the lips, itching, tongue swelling, chest pain, wheezing, and she lost her voice. The patient went to urgent care and was given epinephrine and steroids for the reaction. An ambulance then transported her to the ER (emergency room). The patient was treated in the ER and a D-dimer test was completed to check for pulmonary embolisms. The results showed an increase in the D-dimer test. Treatment with WAKIX was discontinued on 07-MAR-2020. As of(b)(6)******, the events of anxiety, mania, joint pain, increased migraine severity, and anaphylactic reaction (including swelling and burning of the lips, itching, tongue swelling, chest pain, wheezing, and loss of voice) were resolved. The current status of problems with mood and musculoskeletal pain were unknown. No further information could be obtained, as the contact information for the reporter was not provided. Comment: An unknown time (within days) after the start of WAKIX, a 36-year-old female had an anaphylactic reaction with symptoms described as swelling and burning of the lips, itching, tongue swelling, chest pain, wheezing, and losing her voice. She recovered after treatment with epinephrine, steroids, and unspecified medications in the emergency room. Treatment with WAKIX was discontinued on 07-MAR-2020 and the events had resolved. In the absence of alternative etiologies, an association with WAKIX is possible.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:19.048+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "c352e896-13f4-47fb-befb-222562803409", "parentComponentId": null }, { "bbox": { "h": 0.25, "w": 0.86, "x": 0.07, "y": 0.11 }, "kind": "paragraph", "text": "A few days after starting pitolisant (started treatment on Mar 3,2020 and discontinued on Mar 7, suggesting the event occurred in between), a 36-year old female patient experienced mania, migraines, and an anaphylactic reaction “described as swelling and burning of the lips, itching, tongue swelling, chest pain, wheezing, and lost her voice. Patient went to urgent care and was taken by ambulance to an ER. D-dimer test was conducted to check for pulmonary embolism, and “results showed an increase in D-dimer test.” Pitolisant was discontinued and the patient recovered after treatment in the ER with epinephrine and steroids. “In the absence of alternative etiologies, an association with Wakix is possible.”", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:19.048+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "d8763ff1-49ee-404e-97ee-ea9b7d9ca8d0", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "In the absence of alternative etiologies, an association with Wakix is possible. — FDA FAERS Case Report", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:42+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d1-73a9-abb6-aeebfdd7aaf1", "parentComponentId": null }, { "bbox": { "h": 0.02, "w": 0.25, "x": 0.07, "y": 0.95 }, "kind": "source-note", "text": "Source: FDA FAERS – FOIA Case Report Information", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. Numbered footnotes use attrs.numbered." }, "tool": null, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:19.048+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "4c7d34bd-401a-4561-9d42-f7fc7b75c354", "parentComponentId": null }, { "bbox": { "h": 0.03, "w": 0.45, "x": 0.07, "y": 0.07 }, "kind": "title", "text": "Case ID: 17585737, Event date: 2020", "attrs": null, "canon": { "kind": { "name": "Title", "slug": "title", "status": "active", "canonId": "019de52c-f7dd-76d9-b848-b1f12bd85cf4", "version": 1, "description": "Slide title or headline." }, "tool": null, "subkind": { "name": "Headline", "slug": "headline", "status": "active", "canonId": "019de52c-fae1-7463-9a7c-d60668eced0d", "version": 1, "description": null }, "framework": null }, "subkind": "headline", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:19.048+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "2ad4eab6-2307-46f8-a688-32d7e99ae540", "parentComponentId": null } ], "metrics": [], "tools": [], "frameworks": [], "arcBeats": [], "loops": [], "locked": true }, { "page": 200, "type": "appendix", "title": "This is a pharmacovigilance case report summary.", "function": "illustrate_case", "rawType": "other", "block": null, "metadata": { "slideType": "other", "slideTypeCanon": { "name": "Other (fallback)", "slug": "other", "status": "active", "canonId": "019de52d-0af5-71ed-83de-d51ae245fc43", "version": 1, "description": null }, "function": "illustrate_case", "functionCanon": { "name": "Illustrate case", "slug": "illustrate_case", "status": "active", "canonId": "019de52d-13b4-772c-bb73-1873612a7463", "version": 1, "description": null }, "density": "dense", "densityScore": 56, "componentCount": 6, "textChars": 3872, "nDataPoints": 0, "notes": "This is a pharmacovigilance case report summary.", "elementsJson": [ "headline_text", "paragraph", "footnote" ], "confidence": 1, "extraction": { "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "at": "2026-05-02 20:18:14.521+00", "seconds": 5.038, "promptVersion": "v2-canon-conditioned" } }, "links": { "slide": "/slides/019dd923-622c-750b-8b9a-21918ac10c17/200", "deck": "/decks/019dd923-622c-750b-8b9a-21918ac10c17", "deckAnchor": "/decks/019dd923-622c-750b-8b9a-21918ac10c17#slide-200", "deckJson": "/decks/019dd923-622c-750b-8b9a-21918ac10c17.json" }, "components": [ { "bbox": null, "kind": "callout", "text": "Based on the temporal association between event onset and the start of WAKIX, and as the primary inciting events of anxiety and depression are labeled, the subsequent mental health issues and associated dyspnea are assessed as possibly related to WAKIX, which was ongoing as of last report.", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": { "name": "Visual emphasis", "slug": "visual-emphasis", "status": "active", "bestFor": null, "canonId": "019dd9e1-474b-736b-a8eb-a794dd88241c", "version": 1, "bodyDocId": null, "description": "Drawing the eye to one element above the rest of the slide.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-23 01:18:10+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-70f3-714d-84c6-4229e31dba89", "parentComponentId": null }, { "bbox": { "h": 0.45, "w": 0.86, "x": 0.07, "y": 0.41 }, "kind": "paragraph", "text": "On 04-MAY-2020, a solicited report was received from a consumer via a company representative (Case ID: 050420-R114980) regarding a 48-year-old female who was being treated with WAKIX (pitolisant). On 19-MAY-2020, additional information was received from a consumer via a company representative (Case ID: 051920-R114980) and based on the information received the case was reassessed as serious, unexpected, and possibly related to WAKIX. On 01-JUN-2020, additional information was received from a consumer via a company representative (060120-R114980). Medical history and concomitant products were not reported. On 30-APR-2020, the patient started treatment with WAKIX for an unreported indication. On 04-MAY-2020, after starting the product, the patient's MD (presumed to mean medical doctor) felt she had depression and or anxiety, but she did not yet have a confirmed diagnosis. The MD was going to be prescribing a new medication for the anxiety and depression, but the patient was not sure which medication they would prescribe as it depended on her ultimate diagnosis. On (b)(6)*****, it was learned from the patient that she had been hospitalized for \"mental health issues\" and had not taken the product since 11-MAY-2020. She was restarting the product \"now\" (relative to 19-MAY-2020). Since her hospitalization, the patient was newly prescribed Vistaril (hydroxyzine pamoate), Toprol XL (metoprolol succinate), and trazodone (routes, doses, frequencies and indications for use were not reported). As of 04-MAY-2020, the statuses of the patient's anxiety and depression were both unknown and as of 19-MAY-2020, the status of the patient's mental health issues was not reported. No additional information is expected, as contact information for the consumer was not provided. On 01-JUN-2020, the status treatment with WAKIX and outcomes of extreme leg swelling, difficulty catching her breath, and anxiety were ongoing. No additional information is expected, as contact information for the consumer was not provided. Comment: A 48-year-old female, treated with WAKIX since 30-APR-2020, was hospitalized for mental health issues with depression and/or anxiety since 04-MAY-2020, and had not taken the product since 11-MAY-2020. She was newly prescribed Vistaril, Toprol XL, and trazodone, and the outcome was not reported. More recently reported events include transient lower extremity swelling and difficulty catching her breath which was possibly related to anxiety, all of which were ongoing. Based on the temporal association between event onset and the start of WAKIX, and as the primary inciting events of anxiety and depression are labeled, the subsequent mental health issues and associated dyspnea are assessed as possibly related to WAKIX, which was ongoing as of last report. Peripheral edema is confounded by trazodone and Toprol XL, for which edema and peripheral edema are labeled, respectively and unlikely related to WAKIX.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:14.521+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "2c4953e4-1867-47f0-92d0-05023528757d", "parentComponentId": null }, { "bbox": { "h": 0.15, "w": 0.86, "x": 0.07, "y": 0.11 }, "kind": "paragraph", "text": "A 48-year old female patient was hospitalized for mental health issues with depression and/or anxiety, five days after starting pitolisant. Patient also reported “difficulty catching her breath” (dyspnea) and peripheral edema. “Based on the temporal association between event onset and the start of WAKIX, and as the primary inciting events of anxiety and depression are labeled, the subsequent mental health issues and associated dyspnea are assessed as possibly related to WAKIX, which was ongoing as of last report.”", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:14.521+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "d709dbba-074b-47e1-acb8-3cffef20dc47", "parentComponentId": null }, { "bbox": { "h": 0.02, "w": 0.3, "x": 0.07, "y": 0.95 }, "kind": "source-note", "text": "Source: FDA FAERS – FOIA Case Report Information", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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Adverse Event Reporting System (FAERS) FOIA Case Report Information", "attrs": null, "canon": { "kind": { "name": "Image", "slug": "image", "status": "active", "canonId": "019de52c-f978-701f-a720-51d029d769e7", "version": 1, "description": "Photo, illustration, screenshot or icon." }, "tool": null, "subkind": { "name": "Screenshot", "slug": "screenshot", "status": "active", "canonId": "019de52c-fd87-7509-8391-3d79fb339379", "version": 1, "description": null }, "framework": null }, "subkind": "screenshot", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:12.624+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "0df2bbd8-c4ae-4de6-b948-2a188fcdb447", "parentComponentId": null }, { "bbox": { "h": 0.35, "w": 0.86, "x": 0.07, "y": 0.11 }, "kind": "paragraph", "text": "53 year old male patient on 36mg, who stated he is a “heath professional” who has been a “clinical trials coordinator.” He experienced a 9 day gap in getting a refill due to a pharmacy error and “suffered continuous, severe, debilitating headaches” with “extreme nausea.” Symptoms improved within a day when Wakix was refilled. Patient stated that “It's important to note that according to all existing medical literature, to date, there are NO EXISTING REPORTS OF ADVERSE EFFECTS UPON SUDDEN DISCONTINUATION OF WAKIX. Because this is a newly released, novel medication, I thought it was important to report this finding directly to the FDA.” (all caps by patient) We note that pitolisant is marketed as not having any withdrawal symptoms.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:12.624+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "5d3095b9-0722-488b-8ae3-203f42febf48", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "It's important to note that according to all existing medical literature, to date, there are NO EXISTING REPORTS OF ADVERSE EFFECTS UPON SUDDEN DISCONTINUATION OF WAKIX. 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HARMONY 1 compared pitolisant to placebo or modafinil, a $50/month generic wakefulness-promoting drug that’s typically the fist line of treatment. The trial showed that pitolisant was inferior to modafinil in reducing excessive daytime sleepiness (EDS), the primary endpoint, and also inferior in cataplexy. The study claimed pitolisant is slightly superior to placebo, and used that to persuade the FDA that it was still worthy of approval as it’s purportedly safe and not a scheduled substance. The second pivotal trial, HARMONY 1-bis, was an outright debacle and never published. The design was similar to HARMONY 1. Pitolisant failed to show statistically-significant reduction in EDS or cataplexy vs. either placebo or modafinil, and in fact did even worse vs. modafinil than in HARMONY 1.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:14.744+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "05ff0c31-c761-4c62-b59b-1f7d76494ab9", "parentComponentId": null }, { "bbox": { "h": 0.13, "w": 0.38, "x": 0.07, "y": 0.78 }, "kind": "paragraph", "text": "In post-hoc analyses, pitolisant was superior to placebo but not non-inferior to modafinil in terms of improvement in cataplexy rate from baseline (table 2, appendix). In other post-hoc analyses, the percentage of responders (with final ESS scores of 10 or lower) also differed between the pitolisant and placebo groups and were similar between pitolisant and modafinil (table 2).", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:14.744+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "84f5867a-d5e9-41a2-b51c-fd83b83a2e85", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "Harmony 1 trial paper, published 2013 in The Lancet – pitolisant was inferior to modafinil on the primary endpoint of excessive daytime sleepiness as measured by Epworth Sleepiness Scale; final ESS score in pitolisant arm still indicates excessive sleepiness; also inferior on cataplexy reduction — The Lancet", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:40+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d1-73a9-abb5-5e45067f8c2a", "parentComponentId": null }, { "bbox": { "h": 0.03, "w": 0.4, "x": 0.07, "y": 0.94 }, "kind": "source-note", "text": "Source: https://www.thelancet.com/journals/laneur/article/PIIS1474-4422(13)70225-4/fulltext", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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HARMONY CTP (P11-05)", "attrs": null, "canon": { "kind": { "name": "Chart", "slug": "chart", "status": "active", "canonId": "019de52c-f9a0-76ef-adc6-0b859109d1f8", "version": 1, "description": "Quantitative chart." }, "tool": null, "subkind": { "name": "Pie chart", "slug": "pie", "status": "active", "canonId": "019de52c-ffdb-71bb-a800-5c5ab9f1c373", "version": 1, "description": null }, "framework": null }, "subkind": "pie", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:14.541+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "ec131793-ae83-4f45-a6e4-3a55fdc95b81", "parentComponentId": null }, { "bbox": null, "kind": "metric", "text": "study participants by country: 38%", "attrs": null, "canon": { "kind": { "name": "Metric", "slug": "metric", "status": "active", "canonId": "019de52c-f923-73bf-8081-d0b1a8c5264d", "version": 1, "description": "Big-number or KPI value." }, "tool": { "name": "Quantification", "slug": "quantification", "status": "active", "bestFor": null, "canonId": "019dd9e1-47ab-72ce-a079-aab1f5299e88", "version": 1, "bodyDocId": null, "description": "Translating a claim into numbers, charts, or tables.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": "primary", "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:40+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d1-73a9-abb5-04e25fdf9628", "parentComponentId": null }, { "bbox": { "h": 0.22, "w": 0.86, "x": 0.07, "y": 0.19 }, "kind": "paragraph", "text": "While the two previous trials included sleep centers in South America and Hungary, the majority of patients were still enrolled in western Europe. However, CTP appears to have dispensed with western European sleep centers entirely in favor of Russia, Serbia, Turkey, Ukraine, Bulgaria, Poland, Macedonia, Czech Republic, and Hungary. The paper for the trial fails to disclose the distribution of patients by country, and charts buried in an FDA review explain the reticence: 38% of study participants were in Russia, which along with Ukraine, Turkey, Serbia and Hungary comprised ~90%.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:14.541+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "ab884ce3-ccf8-43d9-b496-6a89e60dbf55", "parentComponentId": null }, { "bbox": { "h": 0.12, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "After the abysmal results in these two trials, we suspect Bioprojet went into whatever-it-takes mode and conducted HARMONY CTP in countries where - in our opinion - it simply purchased the outcome it needed.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:14.541+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "ef471511-83e9-4071-a5dd-aeece0c7c986", "parentComponentId": null }, { "bbox": { "h": 0.03, "w": 0.6, "x": 0.07, "y": 0.95 }, "kind": "source-note", "text": "Source: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/211150Orig2s000MedR.pdf; Scorpion Capital estimates and analysis", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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Of the ones published (HARMONY 1, CTP, and 3), the papers omit key data and we can find no record of an appendix or supplementary package with a full data set. However, those omissions pale next to failed phase 3 trials that are simply concealed. An astute reader may notice that Harmony's slide - and FDA submissions - show trials called HARMONY 1 and 3, but curiously no HARMONY 2. Our research indicates a HARMONY 2 trial was in fact conducted - only to fail and be buried, with the oddly-named \"1-bis\" inserted in its place as \"2\" was taken. We found another failed trial called HARMONY 4, also buried. Neither was part of the FDA package. Thus, HARMONY 1, 1-bis, 2, and 4 were all failures. The only trials that \"worked \" were CTP - where they had to find 21 patients in Russia - and Harmony 3, an absurd open-label naturalistic trial that we shall get to. We show below the only available crumbs for HARMONY 2, from a table in the EMA review and ClinicalTrials.gov. The trial planned to enroll 40 patients but was halted midway, in a failed attempt to re-do HARMONY 1, with modafinil as an add-on to pitolisant.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:15.531+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "21f61fd6-11d3-4937-b586-51a4802d03b8", "parentComponentId": null }, { "bbox": { "x": 0.07, "y": 0.82 }, "kind": "paragraph", "text": "Efficacy and Safety Study of BF2.649 and BF2.649 Add on Modafinil on Cataplexy in Patients With Narcolespy (Harmony2)", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:15.531+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "29bc31d5-a1c1-4bab-bc8b-5bf8a4c8bb2a", "parentComponentId": null }, { "bbox": { "x": 0.07, "y": 0.94 }, "kind": "source-note", "text": "Source: EMA review and ClinicalTrials.gov", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. Numbered footnotes use attrs.numbered." }, "tool": null, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:15.531+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "fe411d5f-6bed-48dc-8baf-39ce7ff5dab6", "parentComponentId": null }, { "bbox": { "x": 0.07, "y": 0.69 }, "kind": "table", "text": "EMA review table for HARMONY II trial details", "attrs": null, "canon": { "kind": { "name": "Table", "slug": "table", "status": "active", "canonId": "019de52c-f9c8-7148-8119-eaac9594cd28", "version": 1, "description": "Tabular data layout." }, "tool": null, "subkind": { "name": "Data table", "slug": "data", "status": "active", "canonId": "019de52d-02d5-75b8-8abf-88e92bf63569", "version": 1, "description": null }, "framework": null }, "subkind": "data", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:15.531+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "d07626ea-e9df-43ad-afda-e4d43a04175f", "parentComponentId": null } ], "metrics": [], "tools": [], "frameworks": [ { "matchId": "d06a6675-0152-4ff6-96c4-5aac7be55fba", "evidence": "The slide explicitly documents the concealment of failed clinical trials to mislead stakeholders.", "framework": null, "confidence": 1, "extraction": { "at": "2026-05-02 20:18:15.531+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "pageNumber": 213, "frameworkName": "fraud-exposure" } ], "arcBeats": [], "loops": [], "locked": true }, { "page": 214, "type": "tension", "title": "The slide uses excerpts from French regulatory documents to prove the existence and negative results of the unpublished HARMONY 4 trial.", "function": "expose_contradiction", "rawType": "expose_contradiction", "block": null, "metadata": { "slideType": "expose_contradiction", "slideTypeCanon": { "name": "Expose contradiction", "slug": "expose_contradiction", "status": "active", "canonId": "019de52d-124c-75aa-984a-0a3d0d8fc8df", "version": 1, "description": null }, "function": "expose_contradiction", "functionCanon": { "name": "Expose contradiction", "slug": "expose_contradiction", "status": "active", "canonId": "019de52d-171f-776f-887c-73edaff4cf9c", "version": 1, "description": null }, "density": "dense", "densityScore": 60, "componentCount": 7, "textChars": 2222, "nDataPoints": 0, "notes": "The slide uses excerpts from French regulatory documents to prove the existence and negative results of the unpublished HARMONY 4 trial.", "elementsJson": [ "paragraph", "screenshot" ], "confidence": 1, "extraction": { "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "at": "2026-05-02 20:18:28.214+00", "seconds": 16.053, "promptVersion": "v2-canon-conditioned" } }, "links": { "slide": "/slides/019dd923-622c-750b-8b9a-21918ac10c17/214", "deck": "/decks/019dd923-622c-750b-8b9a-21918ac10c17", "deckAnchor": "/decks/019dd923-622c-750b-8b9a-21918ac10c17#slide-214", "deckJson": "/decks/019dd923-622c-750b-8b9a-21918ac10c17.json" }, "components": [ { "bbox": { "h": 0.05, "w": 0.86, "x": 0.07, "y": 0.62 }, "kind": "callout", "text": "HARMONY 4 info from a 2018 review paper; the paper cites unpublished data provided to the French National Authority for Health, which we located and excerpt below right (from French via Google translate)", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": null, "subkind": { "name": "Primary callout", "slug": "primary", "status": "active", "canonId": "019de52c-fbd1-70eb-a9ce-8997f8674c1d", "version": 1, "description": null }, "framework": null }, "subkind": "primary", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:28.214+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "4d72d4dc-ebf6-475d-ae0e-81db52584589", "parentComponentId": null }, { "bbox": null, "kind": "callout", "text": "The trial showed no difference between the pitolisant group and placebo in ESS, nor secondary endpoints like reduction in cataplexy, quality of life, or maintenance of wakefulness test (MWT).", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": { "name": "Visual emphasis", "slug": "visual-emphasis", "status": "active", "bestFor": null, "canonId": "019dd9e1-474b-736b-a8eb-a794dd88241c", "version": 1, "bodyDocId": null, "description": "Drawing the eye to one element above the rest of the slide.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:41+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d1-73a9-abb5-bf6df445fd9a", "parentComponentId": null }, { "bbox": { "h": 0.23, "w": 0.86, "x": 0.07, "y": 0.69 }, "kind": "image", "text": "Excerpts from French regulatory documents regarding the P10-01 (Harmony IV) study.", "attrs": null, "canon": { "kind": { "name": "Image", "slug": "image", "status": "active", "canonId": "019de52c-f978-701f-a720-51d029d769e7", "version": 1, "description": "Photo, illustration, screenshot or icon." }, "tool": null, "subkind": { "name": "Screenshot", "slug": "screenshot", "status": "active", "canonId": "019de52c-fd87-7509-8391-3d79fb339379", "version": 1, "description": null }, "framework": null }, "subkind": "screenshot", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:28.214+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "84036d27-5655-435b-a095-9eedbb930712", "parentComponentId": null }, { "bbox": { "h": 0.35, "w": 0.86, "x": 0.07, "y": 0.16 }, "kind": "paragraph", "text": "The FDA's failure to incorporate either trial into its review was a grave error, as they were the most relevant, real-world trials conducted. Unlike the monotherapy pivotal trials upon which approval was based, these two trials evaluated pitolisant as an add-on to either modafinil or sodium oxybate, the two most common first line treatments. Our interviews with 20 physicians indicate that those willing to use pitolisant rarely do so as a standalone or first-line option and more typically as the third or fourth addition to a cocktail including modafinil and/or sodium oxybate. Former sales reps indicate the company's entire strategy is to market pitolisant as a combo therapy, given questions about its efficacy. Harmony 4 was conducted between Sep 2012 and Aug 2014, with 51 patients and the same primary endpoint as Harmony 1 – reduction in excessive daytime sleepiness (EDS) using the Epworth Sleepiness Scale (ESS). The trial showed no difference between the pitolisant group and placebo in ESS, nor secondary endpoints like reduction in cataplexy, quality of life, or maintenance of wakefulness test (MWT).", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:28.214+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "1030a714-a3f4-40b6-a2e5-6aa487fce341", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "No difference in terms of daytime sleepiness assessed by the Epworth scale (primary endpoint) was demonstrated between the two groups: at the end of the study the mean score had decreased by 2.6 points in the pitolisant group and 2.1 points in the placebo group (p=0.595). — French National Authority for Health (via Google translate)", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:41+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d1-73a9-abb5-c0a64e0b4ce3", "parentComponentId": null }, { "bbox": { "h": 0.04, "w": 0.86, "x": 0.07, "y": 0.94 }, "kind": "source-note", "text": "Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6124464/; https://www.has-sante.fr/upload/evamed/CT-14970_WAKIX_PIC_INS_Avis3_CT14970.pdf; https://clinicaltrials.gov/ct2/history/NCT01789398?A=1&B=9&C=merged#StudyPageTop", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. Numbered footnotes use attrs.numbered." }, "tool": null, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:28.214+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "5aaab45a-32b2-4e3f-a1a3-a1960fad60c2", "parentComponentId": null }, { "bbox": { "h": 0.08, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "title", "text": "HARMONY 4 was a debacle similar to HARMONY 2, and also never published.", "attrs": null, "canon": { "kind": { "name": "Title", "slug": "title", "status": "active", "canonId": "019de52c-f7dd-76d9-b848-b1f12bd85cf4", "version": 1, "description": "Slide title or headline." }, "tool": null, "subkind": { "name": "Headline", "slug": "headline", "status": "active", "canonId": "019de52c-fae1-7463-9a7c-d60668eced0d", "version": 1, "description": null }, "framework": null }, "subkind": "headline", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:28.214+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "a569af24-d43e-45f6-9d37-b4e8407db627", "parentComponentId": null } ], "metrics": [], "tools": [], "frameworks": [ { "matchId": "bf96bd42-3e5c-4f5d-ae92-392e130db14a", "evidence": "The slide explicitly highlights the omission of negative trial data by the FDA to support a narrative of regulatory failure.", "framework": null, "confidence": 0.9, "extraction": { "at": "2026-05-02 20:18:28.214+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "pageNumber": 214, "frameworkName": "fraud-exposure" } ], "arcBeats": [], "loops": [], "locked": true }, { "page": 215, "type": "tension", "title": "The slide functions as a 'fraud-exposure' or 'villain-critique' framework, systematically dismantling the credibility of the clinical trial data.", "function": "expose_contradiction", "rawType": "preempt_rebuttal", "block": null, "metadata": { "slideType": "preempt_rebuttal", "slideTypeCanon": { "name": "Preempt rebuttal", "slug": "preempt_rebuttal", "status": "active", "canonId": "019de52d-1225-7368-af32-6381fddabdb3", "version": 1, "description": null }, "function": "expose_contradiction", "functionCanon": { "name": "Expose contradiction", "slug": "expose_contradiction", "status": "active", "canonId": "019de52d-171f-776f-887c-73edaff4cf9c", "version": 1, "description": null }, "density": "sparse", "densityScore": 20, "componentCount": 3, "textChars": 810, "nDataPoints": 0, "notes": "The slide functions as a 'fraud-exposure' or 'villain-critique' framework, systematically dismantling the credibility of the clinical trial data.", "elementsJson": [ "paragraph", "numbered_list" ], "confidence": 1, "extraction": { "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "at": "2026-05-02 20:18:14.767+00", "seconds": 2.535, "promptVersion": "v2-canon-conditioned" } }, "links": { "slide": "/slides/019dd923-622c-750b-8b9a-21918ac10c17/215", "deck": "/decks/019dd923-622c-750b-8b9a-21918ac10c17", "deckAnchor": "/decks/019dd923-622c-750b-8b9a-21918ac10c17#slide-215", "deckJson": "/decks/019dd923-622c-750b-8b9a-21918ac10c17.json" }, "components": [ { "bbox": null, "kind": "callout", "text": "The pages ahead will highlight red flags, statistical tricks, and omissions in the principal trials upon which FDA approval was based – HARMONY 1, 1-bis, CTP, and 3.", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": { "name": "Visual emphasis", "slug": "visual-emphasis", "status": "active", "bestFor": null, "canonId": "019dd9e1-474b-736b-a8eb-a794dd88241c", "version": 1, "bodyDocId": null, "description": "Drawing the eye to one element above the rest of the slide.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:44+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d1-73a9-abb7-bea9db52912f", "parentComponentId": null }, { "bbox": { "h": 0.68, "w": 0.86, "x": 0.07, "y": 0.24 }, "kind": "list", "text": "1. Only 'successful' trials are presented... 2. Published papers for trials are missing... 3. Trials are conducted in low-quality geographies... 4. Unreasonably short trial and timelines... 5. Cherry-picked trial intervals... 6. Fuzzy inclusion criteria... 7. Trials excluded patients with comorbidities... 8. Low quality primary endpoint using ESS.", "attrs": null, "canon": { "kind": { "name": "List", "slug": "list", "status": "active", "canonId": "019de52c-f94b-779b-a53b-fd4904a5f4d2", "version": 1, "description": "Bullet or numbered list." }, "tool": null, "subkind": { "name": "Numbered list", "slug": "numbered", "status": "active", "canonId": "019de52c-fcc0-7718-a284-a4250c805df2", "version": 1, "description": null }, "framework": null }, "subkind": "numbered", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:14.767+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "352dacf8-e90e-4a98-853f-eb6573578238", "parentComponentId": null }, { "bbox": { "h": 0.15, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "The pages ahead will highlight red flags, statistical tricks, and omissions in the principal trials upon which FDA approval was based – HARMONY 1, 1-bis, CTP, and 3. We discuss each trial one by one, but first we summarize the modus operandi and problems common to the pitolisant clinical trials.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:14.767+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "1531b60b-bfc1-42bc-9c38-b3de13c87f51", "parentComponentId": null } ], "metrics": [], "tools": [], "frameworks": [ { "matchId": "c6221f8f-4d4b-4495-91ad-c6c8939da11c", "evidence": "Systematic listing of methodological flaws and data manipulation allegations.", "framework": null, "confidence": 0.95, "extraction": { "at": "2026-05-02 20:18:14.767+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "pageNumber": 215, "frameworkName": "fraud-exposure" } ], "arcBeats": [], "loops": [], "locked": true }, { "page": 216, "type": "setup", "title": "This slide serves as a critical audit of clinical trial integrity, focusing on statistical manipulation and poor trial design.", "function": "preempt_rebuttal", "rawType": "preempt_rebuttal", "block": null, "metadata": { "slideType": "preempt_rebuttal", "slideTypeCanon": { "name": "Preempt rebuttal", "slug": "preempt_rebuttal", "status": "active", "canonId": "019de52d-1225-7368-af32-6381fddabdb3", "version": 1, "description": null }, "function": "preempt_rebuttal", "functionCanon": { "name": "Preempt rebuttal", "slug": "preempt_rebuttal", "status": "active", "canonId": "019de52d-18ab-7479-9a7e-820a2f03586a", "version": 1, "description": null }, "density": "balanced", "densityScore": 35, "componentCount": 3, "textChars": 1659, "nDataPoints": 0, "notes": "This slide serves as a critical audit of clinical trial integrity, focusing on statistical manipulation and poor trial design.", "elementsJson": [ "headline_text", "numbered_list" ], "confidence": 1, "extraction": { "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "at": "2026-05-02 20:18:15.236+00", "seconds": 2.913, "promptVersion": "v2-canon-conditioned" } }, "links": { "slide": "/slides/019dd923-622c-750b-8b9a-21918ac10c17/216", "deck": "/decks/019dd923-622c-750b-8b9a-21918ac10c17", "deckAnchor": "/decks/019dd923-622c-750b-8b9a-21918ac10c17#slide-216", "deckJson": "/decks/019dd923-622c-750b-8b9a-21918ac10c17.json" }, "components": [ { "bbox": null, "kind": "callout", "text": "Statistical tricks and obfuscations such as artificially clustering trial sites after the fact to adjust p-values; incoherent, bespoke statistical methodologies meant to be impenetrable.", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": { "name": "Visual emphasis", "slug": "visual-emphasis", "status": "active", "bestFor": null, "canonId": "019dd9e1-474b-736b-a8eb-a794dd88241c", "version": 1, "bodyDocId": null, "description": "Drawing the eye to one element above the rest of the slide.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:45+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d1-73a9-abb8-7684067ac714", "parentComponentId": null }, { "bbox": { "h": 0.75, "w": 0.86, "x": 0.07, "y": 0.12 }, "kind": "list", "text": "9. No histologic endpoints or data is ever presented. Levels of histamine and/or its metabolites were never shown, nor were CSF hypocretin levels, a narcolepsy marker per ICSD diagnostic criteria.\n10. EDS reductions per ESS are modest even in trials gamed to show statistical significance vs. placebo, and final levels are still excessive, indicating results are statistically significant but clinically irrelevant.\n11. Huge placebo effect across trials; no dose response\n12. No combination trials that reflect its real-world use case, as it is almost exclusively used as a 3rd or 4th line drug in a cocktail.\n13. Trials expanded midway, typically a sign of a failing trial that’s scrounging for a small signal by expanding the sample size; other shifting goalposts and endpoint and protocol changes, often undisclosed.\n14. Flexible dosing that’s all over the place, with doses titrated up or down at each investigators whimsy from 5mg to 40mg.\n15. Concomitant medications were allowed, creating a massive confounding factor as patients were generally on cocktails of drugs\n16. 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the entire foundation of Harmony’s clinical trials and the key “evidence” of its purported efficacy - is a highly unreliable, unvalidated, subjective, patient-reported questionnaire that assesses chances of falling asleep in different settings.", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": { "name": "Visual emphasis", "slug": "visual-emphasis", "status": "active", "bestFor": null, "canonId": "019dd9e1-474b-736b-a8eb-a794dd88241c", "version": 1, "bodyDocId": null, "description": "Drawing the eye to one element above the rest of the slide.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:41+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d1-73a9-abb5-d77b27cb2c3c", "parentComponentId": null }, { "bbox": { "x": 0.07, "y": 0.59 }, "kind": "image", "text": "Screenshot of the Epworth Sleepiness Scale website", "attrs": null, "canon": { "kind": { "name": "Image", "slug": "image", "status": "active", "canonId": "019de52c-f978-701f-a720-51d029d769e7", "version": 1, "description": "Photo, illustration, screenshot or icon." }, "tool": null, "subkind": { "name": "Screenshot", "slug": "screenshot", "status": "active", "canonId": "019de52c-fd87-7509-8391-3d79fb339379", "version": 1, "description": null }, "framework": null }, "subkind": "screenshot", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:15.006+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "558162c8-f66a-4703-bacb-03fe88f8ec24", "parentComponentId": null }, { "bbox": { "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "We begin with HARMONY 1, a phase 3 RCT that compared pitolisant versus placebo or modafinil. The primary endpoint was change in Epworth Sleepiness Scale (ESS) scores between the pitolisant and placebo groups after 8 weeks of treatment. ESS – the entire foundation of Harmony’s clinical trials and the key “evidence” of its purported efficacy - is a highly unreliable, unvalidated, subjective, patient-reported questionnaire that assesses chances of falling asleep in different settings. 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Reproducibility of the Epworth Sleepiness Scale\nLow test–retest reliability of the Epworth Sleepiness Scale within a substantial short time frame", "attrs": null, "canon": { "kind": { "name": "List", "slug": "list", "status": "active", "canonId": "019de52c-f94b-779b-a53b-fd4904a5f4d2", "version": 1, "description": "Bullet or numbered list." }, "tool": null, "subkind": { "name": "Bullet list", "slug": "bullet", "status": "active", "canonId": "019de52c-fc98-7169-a083-5cab805076ca", "version": 1, "description": null }, "framework": null }, "subkind": "bullet", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:16.823+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "66b4dcf5-c6f5-48e4-9afa-6ee70fefd1ff", "parentComponentId": null }, { "bbox": { "h": 0.15, "w": 0.86, "x": 0.07, "y": 0.19 }, "kind": "paragraph", "text": "The Editor-In-Chief of the Journal of Clinical Sleep 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null, "metadata": { "slideType": "expose_contradiction", "slideTypeCanon": { "name": "Expose contradiction", "slug": "expose_contradiction", "status": "active", "canonId": "019de52d-124c-75aa-984a-0a3d0d8fc8df", "version": 1, "description": null }, "function": "expose_contradiction", "functionCanon": { "name": "Expose contradiction", "slug": "expose_contradiction", "status": "active", "canonId": "019de52d-171f-776f-887c-73edaff4cf9c", "version": 1, "description": null }, "density": "dense", "densityScore": 52, "componentCount": 7, "textChars": 877, "nDataPoints": 48, "notes": "The slide uses FDA biometrics review data to challenge the efficacy timeline of the drug Wakix (pitolisant).", "elementsJson": [ "paragraph", "data_table", "callout_box" ], "confidence": 1, "extraction": { "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "at": "2026-05-02 20:18:20.149+00", "seconds": 6.966, "promptVersion": "v2-canon-conditioned" } }, "links": { "slide": "/slides/019dd923-622c-750b-8b9a-21918ac10c17/222", "deck": "/decks/019dd923-622c-750b-8b9a-21918ac10c17", "deckAnchor": "/decks/019dd923-622c-750b-8b9a-21918ac10c17#slide-222", "deckJson": "/decks/019dd923-622c-750b-8b9a-21918ac10c17.json" }, "components": [ { "bbox": { "h": 0.15, "w": 0.35, "x": 0.55, "y": 0.65 }, "kind": "callout", "text": "No separation vs. placebo after weeks 2 and 3 (visits 4 and 5), whether looking at absolute ESS scores or the decline from baseline to final outcome", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": null, "subkind": { "name": "Primary callout", "slug": "primary", "status": "active", "canonId": "019de52c-fbd1-70eb-a9ce-8997f8674c1d", "version": 1, "description": null }, "framework": null }, "subkind": "primary", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 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"019dd953-64d1-73a9-abb6-4ddd06746616", "parentComponentId": null }, { "bbox": { "h": 0.15, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "Moreover, pitolisant showed no separation from placebo after week 2 - in fact a small reversal in separation. The bulk of the treatment effect in the trial occurred within weeks 2 and 3, contradicting the Wakix label which indicates it may take 8 weeks to achieve an effect.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:20.149+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "623ee823-b28e-475c-bdff-9234a35ab0c0", "parentComponentId": null }, { "bbox": { "h": 0.02, "w": 0.6, "x": 0.07, "y": 0.94 }, "kind": "source-note", "text": "Source: https://www.accessdata.fda.gov/drugsattda_docs/nda/2021/211150Orig2s000StatR.pdf; Scorpion Capital analysis and estimates", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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The final value in the table is the mean of weeks 7 and 8 (visits 6 and 7). 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The chart also correctly shows the baseline score for pitolisant. However, the final score for pitolisant in the table is 12.0, while the chart shows it as ~10.7 (visually estimated) for week 8 (visit 7). If the chart reflected the value in the table, which appears to be the correct one given multiple references in the paper, it would show a quick and sharp reversal of the pitolisant trend after week 3 (visit 5), undermining the results and necessitating data longer than 8 weeks, which the trials clearly try to avoid with the absurdly short duration.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:16.615+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "adc6ec1c-7412-4f7e-b50d-761cfe828b20", "parentComponentId": null }, { "bbox": { "h": 0.03, "w": 0.5, "x": 0.07, "y": 0.95 }, "kind": "source-note", "text": "Source: https://pubmed.ncbi.nlm.nih.gov/24107292/; https://epworthsleepinessscale.com/about-the-ess/", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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excerpt", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": null, "subkind": { "name": "Primary callout", "slug": "primary", "status": "active", "canonId": "019de52c-fbd1-70eb-a9ce-8997f8674c1d", "version": 1, "description": null }, "framework": null }, "subkind": "primary", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:21.934+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "8972602c-8daa-468d-b818-12e4349c424a", "parentComponentId": null }, { "bbox": { "h": 0.03, "w": 0.86, "x": 0.07, "y": 0.5 }, "kind": "callout", "text": "Harmony 1 trial paper makes no mention of trial expansion and makes the n of 100 appear pre-specified", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": null, "subkind": { "name": "Primary callout", "slug": "primary", "status": "active", "canonId": "019de52c-fbd1-70eb-a9ce-8997f8674c1d", "version": 1, "description": null }, "framework": null }, "subkind": "primary", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:21.934+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "8b7713be-4629-4514-812d-164f58daaf50", "parentComponentId": null }, { "bbox": null, "kind": "callout", "text": "Mid-trial study adjustments which expand the sample size are a red flag and predictive of a flop, as they suggest that the study is failing to show statistical significance and using a larger n to fish for a smaller effect.", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": { "name": "Visual emphasis", "slug": "visual-emphasis", "status": "active", "bestFor": null, "canonId": "019dd9e1-474b-736b-a8eb-a794dd88241c", "version": 1, "bodyDocId": null, "description": "Drawing the eye to one element above the rest of the slide.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:42+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d1-73a9-abb6-97d4490883c4", "parentComponentId": null }, { "bbox": { "h": 0.12, "w": 0.55, "x": 0.07, "y": 0.8 }, "kind": "image", "text": "ClinicalTrials.gov archive\nHistory of Changes for Study: NCT01067222\nEfficacy and Safety Study of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy (Harmony1)\nEnrollment: 60 [Anticipated] 110 [Actual]", "attrs": null, "canon": { "kind": { "name": "Image", "slug": "image", "status": "active", "canonId": "019de52c-f978-701f-a720-51d029d769e7", "version": 1, "description": "Photo, illustration, screenshot or icon." }, "tool": null, "subkind": { "name": "Screenshot", "slug": "screenshot", "status": "active", "canonId": "019de52c-fd87-7509-8391-3d79fb339379", "version": 1, "description": null }, "framework": null }, "subkind": "screenshot", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:21.934+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "a5ba4fb0-89ca-4d0c-bbb1-3b81c2c46d50", "parentComponentId": null }, { "bbox": { "h": 0.42, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "As clinically immaterial as the small ESS reductions in HARMONY 1 are, it appears Bioprojet had to double to trial size mid-way in order to conjure them. The paper makes no mention of a trial expansion, and is written to represent that the final powering of 110 was pre-specified. However, the history of changes for the trial’s record on ClinicalTrials.gov indicates it originally planned to enroll only 60 patients. Mid-trial study adjustments which expand the sample size are a red flag and predictive of a flop, as they suggest that the study is failing to show statistical significance and using a larger n to fish for a smaller effect. Common sense indicates that if a study is pointing to efficacy, one has no incentive to expand the size and rock the boat. Such protocol changes are particularly damning because they mean the sponsor was getting results and modifying the trial with knowledge of day-to-day data.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:21.934+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "3fe19570-1879-4558-be6b-278f1a456ac5", "parentComponentId": null }, { "bbox": { "h": 0.18, "w": 0.38, "x": 0.07, "y": 0.54 }, "kind": "paragraph", "text": "Statistical analysis\nWe calculated the sample size on the basis of data from previous trials,20,21 based on the minimum clinically relevant difference on a final ESS of 3 points, ESS SD of 5, and a coefficient of correlation r (baseline ESS, final ESS) of 0·65. The first test (difference in change of ≥3 points detectable with a power ≥95%) and the second test (non-inferiority margin of 2 points and 80% as minimal power) needed a sample size of 30 patients per group.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:21.934+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "eeab9028-8191-4bd3-b908-a8c8299a1a20", "parentComponentId": null }, { "bbox": { "h": 0.03, "w": 0.68, "x": 0.07, "y": 0.95 }, "kind": "source-note", "text": "Source: https://pubmed.ncbi.nlm.nih.gov/24107292/; https://clinicaltrials.gov/ct2/history/NCT01067222?A=1&B=4&C=merged#StudyPageTop", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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A table in the FDA review shows the hodgepodge of confounding medications taken during the trial across all 3 arms – for example, 23% of pitolisant patients remained on anti-depressants vs. only 13% in the placebo group. Shockingly, 10% of pitolisant patients vs. none in the other arms took “other antihistamines,” which is particularly confounding as pitolisant targets a histamine receptor.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:20.861+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "18aa6bbf-520c-4303-b3cd-55ffdf86d9b1", "parentComponentId": null }, { "bbox": { "h": 0.15, "w": 0.86, "x": 0.07, "y": 0.22 }, "kind": "paragraph", "text": "The protocol stated that patients could remain on anti-cataplectic drugs like sodium oxybate or antidepressants. However, anti-cataplectic drugs are also used to treat narcolepsy symptoms like EDS, making any distinction between narcolepsy and cataplexy drugs irrelevant – and 81% of patients in the pitolisant arm (25/31) had a history of cataplexy.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:20.861+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "ccee85eb-bbe5-4b7b-b62b-8543fc98bd63", "parentComponentId": null }, { "bbox": { "h": 0.03, "w": 0.65, "x": 0.07, "y": 0.95 }, "kind": "source-note", "text": "Source: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/211150Orig2s000MedR.pdf; : https://pubmed.ncbi.nlm.nih.gov/24107292", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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"notes": "The slide uses a direct quote from a Lancet letter to undermine the credibility of the HARMONY 1 trial investigators.", "elementsJson": [ "paragraph", "quote_block", "footnote" ], "confidence": 1, "extraction": { "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "at": "2026-05-02 20:18:17.515+00", "seconds": 3.619, "promptVersion": "v2-canon-conditioned" } }, "links": { "slide": "/slides/019dd923-622c-750b-8b9a-21918ac10c17/226", "deck": "/decks/019dd923-622c-750b-8b9a-21918ac10c17", "deckAnchor": "/decks/019dd923-622c-750b-8b9a-21918ac10c17#slide-226", "deckJson": "/decks/019dd923-622c-750b-8b9a-21918ac10c17.json" }, "components": [ { "bbox": null, "kind": "callout", "text": "Whatever statements the author is referring to strike us as fiction, as we are aware of no such trial that enrolled drug-free patients.", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": { "name": "Visual emphasis", "slug": "visual-emphasis", "status": "active", "bestFor": null, "canonId": "019dd9e1-474b-736b-a8eb-a794dd88241c", "version": 1, "bodyDocId": null, "description": "Drawing the eye to one element above the rest of the slide.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:42+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d1-73a9-abb6-c1b00d5a0d2a", "parentComponentId": null }, { "bbox": { "h": 0.415, "w": 0.852, "x": 0.074, "y": 0.068 }, "kind": "paragraph", "text": "Comments published in The Lancet in conjunction with the HARMONY 1 paper critiqued the short 8-week duration of the study – “not a trivial limitation” – in addition to noting that a large percentage of patients remained on anti-cataplectic medications, which meant that “the effect of pitolisant on cataplexy could not be assessed.” The author of the letter, a neuroscientist focused on sleep disorders, stated that the trial investigators “reported that trials...in drug-free patients...are ongoing. The results of these trials will clarify whether pitolisant is a novel alternative treatment for narcolepsy.” Whatever statements the author is referring to strike us as fiction, as we are aware of no such trial that enrolled drug-free patients. Each of the principal trials submitted to the FDA as evidence allowed the use of an extensive array of concomitant medications.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:17.515+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "c4cc33aa-bd23-4d48-b99e-9f76908a7534", "parentComponentId": null }, { "bbox": { "h": 0.415, "w": 0.46, "x": 0.074, "y": 0.513 }, "kind": "quote", "text": "These results are interesting. However, the short duration of the study (8 weeks) is not a trivial limitation; this short timeframe does not allow assessment of the tolerance that might develop with long-term use. Another crucial point of the study is the assessment of cataplexy: 35% of patients continued their usual anticataplectic medication during the trial, thus the effect of pitolisant on cataplexy could not be fully assessed. The investigators reported that trials assessing the possible anticataplectic activity of pitolisant in drug-free patients as well as long-term trials assessing the effects on EDS are ongoing. The results of these trials will clarify whether pitolisant is a novel alternative treatment for narcolepsy.", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": null, "subkind": { "name": "Pull quote", "slug": "pull-quote", "status": "active", "canonId": "019de52c-fbf9-76fe-97e1-a0b7540445c9", "version": 1, "description": null }, "framework": null }, "subkind": "pull-quote", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:17.515+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "79b7d001-6a91-427c-95fb-f8efc711a3be", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "“not a trivial limitation” — The Lancet. “the effect of pitolisant on cataplexy could not be assessed.” — The Lancet. “reported that trials...in drug-free patients...are ongoing. The results of these trials will clarify whether pitolisant is a novel alternative treatment for narcolepsy.” — The Lancet.", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:42+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d1-73a9-abb6-c7e35b1ba2b3", "parentComponentId": null }, { "bbox": { "h": 0.018, "w": 0.447, "x": 0.074, "y": 0.955 }, "kind": "source-note", "text": "Source: https://www.thelancet.com/pdfs/journals/laneur/PIIS1474-4422(13)70178-9.pdf", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. Numbered footnotes use attrs.numbered." }, "tool": null, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:17.515+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "ea57c001-7e9d-4747-80d0-7a2175ea7366", "parentComponentId": null }, { "bbox": { "h": 0.025, "w": 0.688, "x": 0.074, "y": 0.478 }, "kind": "title", "text": "Letter critical of HARMONY 1, published commensurately in The Lancet, 2013", "attrs": null, "canon": { "kind": { "name": "Title", "slug": "title", "status": "active", "canonId": "019de52c-f7dd-76d9-b848-b1f12bd85cf4", "version": 1, "description": "Slide title or headline." }, "tool": null, "subkind": { "name": "Headline", "slug": "headline", "status": "active", "canonId": "019de52c-fae1-7463-9a7c-d60668eced0d", "version": 1, "description": null }, "framework": null }, "subkind": "headline", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:17.515+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "dff15e2b-66fd-49a6-aa9f-387506cc9d09", "parentComponentId": null } ], "metrics": [], "tools": [], "frameworks": [], "arcBeats": [], "loops": [], "locked": true }, { "page": 227, "type": "tension", "title": "The slide highlights a discrepancy between the reported trial results and the underlying patient-level data regarding dosage and efficacy.", "function": "expose_contradiction", "rawType": "expose_contradiction", "block": null, "metadata": { "slideType": "expose_contradiction", "slideTypeCanon": { "name": "Expose contradiction", "slug": "expose_contradiction", "status": "active", "canonId": "019de52d-124c-75aa-984a-0a3d0d8fc8df", "version": 1, "description": null }, "function": "expose_contradiction", "functionCanon": { "name": "Expose contradiction", "slug": "expose_contradiction", "status": "active", "canonId": "019de52d-171f-776f-887c-73edaff4cf9c", "version": 1, "description": null }, "density": "overcrowded", "densityScore": 89, "componentCount": 11, "textChars": 1800, "nDataPoints": 24, "notes": "The slide highlights a discrepancy between the reported trial results and the underlying patient-level data regarding dosage and efficacy.", "elementsJson": [ "paragraph", "data_table" ], "confidence": 1, "extraction": { "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "at": "2026-05-02 20:18:23.062+00", "seconds": 9.118, "promptVersion": "v2-canon-conditioned" } }, "links": { "slide": "/slides/019dd923-622c-750b-8b9a-21918ac10c17/227", "deck": "/decks/019dd923-622c-750b-8b9a-21918ac10c17", "deckAnchor": "/decks/019dd923-622c-750b-8b9a-21918ac10c17#slide-227", "deckJson": "/decks/019dd923-622c-750b-8b9a-21918ac10c17.json" }, "components": [ { "bbox": null, "kind": "callout", "text": "In other words, patients on the higher dose did far worse, and it appears that statistical significance vs. placebo was driven by the tiny 20mg subgroup.", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": { "name": "Visual emphasis", "slug": "visual-emphasis", "status": "active", "bestFor": null, "canonId": "019dd9e1-474b-736b-a8eb-a794dd88241c", "version": 1, "bodyDocId": null, "description": "Drawing the eye to one element above the rest of the slide.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:46+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d1-73a9-abb8-9a72cdf016fc", "parentComponentId": null }, { "bbox": null, "kind": "metric", "text": "ESS score improvement: 70%", "attrs": null, "canon": { "kind": { "name": "Metric", "slug": "metric", "status": "active", "canonId": "019de52c-f923-73bf-8081-d0b1a8c5264d", "version": 1, "description": "Big-number or KPI value." }, "tool": { "name": "Quantification", "slug": "quantification", "status": "active", "bestFor": null, "canonId": "019dd9e1-47ab-72ce-a079-aab1f5299e88", "version": 1, "bodyDocId": null, "description": "Translating a claim into numbers, charts, or tables.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": "primary", "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:46+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d1-73a9-abb8-9e575b92a863", "parentComponentId": null }, { "bbox": { "h": 0.15, "w": 0.86, "x": 0.07, "y": 0.43 }, "kind": "paragraph", "text": "A second table shows that the 8 patients who remained on 20mg had ESS score improvements 70% greater than those on 40mg (-9.1 vs. -5.1). In other words, patients on the higher dose did far worse, and it appears that statistical significance vs. placebo was driven by the tiny 20mg subgroup.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:23.062+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "6af7665a-c1fe-4936-9a57-60878b1cb500", "parentComponentId": null }, { "bbox": { "h": 0.12, "w": 0.86, "x": 0.07, "y": 0.19 }, "kind": "paragraph", "text": "Patients in the treatment arm could receive 10, 20, or 40 mg of pitolisant. Critically, the paper fails to disclose the number of 31 pitolisant patients by dose, and nor does it show efficacy results on EDS or secondary measures for dosage subgroups.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:23.062+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "94b011f0-c4b4-4787-a884-9a14ff223ccd", "parentComponentId": null }, { "bbox": { "h": 0.12, "w": 0.86, "x": 0.07, "y": 0.31 }, "kind": "paragraph", "text": "Two tables buried in the EMA review explain why the paper was less than forthcoming. One reveals that 19 patients (61%) had to be titrated to the highest dose (40mg), suggesting lack of efficacy during the first half of the trial.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:23.062+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "b3df2f2a-6fd5-4305-b06a-6c99287d87dd", "parentComponentId": null }, { "bbox": { "h": 0.15, "w": 0.86, "x": 0.07, "y": 0.58 }, "kind": "paragraph", "text": "The mean final ESS score in the 18-patient 40mg group was 13.4 vs. 15.6 for placebo – that is, the results were not statistically significant for the largest subgroup. Furthermore, this calls into question the chart of ESS scores by week (slide ___), which shows that the largest drop is in weeks 2 and 3 – if true, why were 18 of 31 patients titrated to double the dose after week 3?", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:23.062+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "bc915f33-ebd2-4eff-85a5-c2cf62b9886c", "parentComponentId": null }, { "bbox": { "h": 0.03, "w": 0.5, "x": 0.07, "y": 0.95 }, "kind": "source-note", "text": "Source: https://www.ema.europa.eu/en/documents/assessment-report/wakix-epar-public-assessment-report_en.pdf", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. Numbered footnotes use attrs.numbered." }, "tool": null, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:23.062+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "ba0efc89-1238-4e2d-baf8-7c3c5da5cd7a", "parentComponentId": null }, { "bbox": { "h": 0.15, "w": 0.43, "x": 0.07, "y": 0.78 }, "kind": "table", "text": "Table 10. Summary of stable dose stage [% (n)] in Harmony I study.", "attrs": null, "canon": { "kind": { "name": "Table", "slug": "table", "status": "active", "canonId": "019de52c-f9c8-7148-8119-eaac9594cd28", "version": 1, "description": "Tabular data layout." }, "tool": null, "subkind": { "name": "Data table", "slug": "data", "status": "active", "canonId": "019de52d-02d5-75b8-8abf-88e92bf63569", "version": 1, "description": null }, "framework": null }, "subkind": "data", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:23.062+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "32d26c1a-906c-4049-8e90-67da6ed563be", "parentComponentId": null }, { "bbox": { "h": 0.15, "w": 0.42, "x": 0.51, "y": 0.78 }, "kind": "table", "text": "Table 11. Summary of ESS by pitolisant stable dose [Mean ± SD] in Harmony I study.", "attrs": null, "canon": { "kind": { "name": "Table", "slug": "table", "status": "active", "canonId": "019de52c-f9c8-7148-8119-eaac9594cd28", "version": 1, "description": "Tabular data layout." }, "tool": null, "subkind": { "name": "Data table", "slug": "data", "status": "active", "canonId": "019de52d-02d5-75b8-8abf-88e92bf63569", "version": 1, "description": null }, "framework": null }, "subkind": "data", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:23.062+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "b7526c93-fd73-4e29-b7aa-d78dc48850bf", "parentComponentId": null }, { "bbox": { "h": 0.12, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "title", "text": "HARMONY 1 and the other pivotal trials also used a flexible dosing schedule, and failed to show a dose response – another red flag.", "attrs": 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HARMONY CTP used the same gimmick, which both agencies missed – a buried footnote states the", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:19.104+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "12f4d079-2f6a-4a6b-9098-a94572743a15", "parentComponentId": null }, { "bbox": { "h": 0.12, "w": 0.86, "x": 0.07, "y": 0.15 }, "kind": "paragraph", "text": "Impenetrable phrases and assumptions are flung with abandon, a black box of statistical jargon and sorcery devoid of details necessary to comprehend or check the calculations. A recurring trick in the trials is what they call “small centres reallocation,”", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:19.104+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "1b64858c-3559-425f-b23b-63ab9337a915", "parentComponentId": null }, { "bbox": { "h": 0.12, "w": 0.86, "x": 0.07, "y": 0.27 }, "kind": "paragraph", "text": "a mysterious post-hoc (after-the-fact) “adjustment” that takes endpoint data by trial site and tosses it into a martini shaker until the desired output spills out. The HARMONY I-bis study was a failure, as we shortly explain, where they tried a post-hoc", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:19.104+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "3b5b9b08-8c03-493e-8183-ec9bfef52883", "parentComponentId": null }, { "bbox": { "h": 0.06, "w": 0.86, "x": 0.07, "y": 0.51 }, "kind": "paragraph", "text": "“centre effect” was “suggested” by HARMONY 1, which also employs the same adjustment and was again missed by the FDA – which is significant given their reaction to it in HARMONY 1-bis.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:19.104+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "901136fd-30c6-4798-9e60-f7f899137374", "parentComponentId": null }, { "bbox": { "h": 0.28, "w": 0.45, "x": 0.07, "y": 0.62 }, "kind": "paragraph", "text": "We adjusted final ESS for baseline values for assessment of the primary endpoint using a mixed linear analysis of covariance, assuming absence of treatment-baseline interaction term and accounting for random centre heterogeneity. Baseline ESS was the exposure at fixed dose); the primary efficacy outcome is cataplexy reduction identified as the rate ratio (pitolisant WCRfb/placebo WCRfb) between basal and final periods; the 1-month stable medication period is considered for final outcome assessment; and a centre effect, suggested by a previous study7 is taken into account. All the", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:19.104+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "daff5f17-0537-4079-9501-ddfc89bbc3a2", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "Footnote 7 in HARMONY CTP mentions HARMONY 1 as the inspiration for the “centres” reallocation, also used in HARMONY 1-bis — Scorpion Capital", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:43+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d1-73a9-abb6-f997ff6f463c", "parentComponentId": null }, { "bbox": { "h": 0.06, "w": 0.4, "x": 0.53, "y": 0.77 }, "kind": "source-note", "text": "7 Dauvilliers Y, Bassetti C, Lammers GJ, et al. Pitolisant versus placebo or modafinil in patients with narcolepsy: a double-blind, randomised trial. Lancet Neurol 2013; 12: 1068–75.", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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Numbered footnotes use attrs.numbered." }, "tool": null, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:19.104+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "e54cb749-9cdb-4064-b2bc-27d7d1b8f3a0", "parentComponentId": null }, { "bbox": { "h": 0.08, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "title", "text": "Statistical tricks and gimmicks are a defining feature of each Bioprojet/Harmony clinical trial.", "attrs": null, "canon": { "kind": { "name": "Title", "slug": "title", "status": "active", "canonId": "019de52c-f7dd-76d9-b848-b1f12bd85cf4", "version": 1, "description": "Slide title or headline." }, "tool": null, "subkind": { "name": "Headline", "slug": "headline", "status": "active", "canonId": "019de52c-fae1-7463-9a7c-d60668eced0d", "version": 1, "description": null }, "framework": null }, "subkind": 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"text": "FDA quotes the EMA’s criticism of HARMONY 1-bis post-hoc analysis as unplanned, but gave a free pass", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": null, "subkind": { "name": "Primary callout", "slug": "primary", "status": "active", "canonId": "019de52c-fbd1-70eb-a9ce-8997f8674c1d", "version": 1, "description": null }, "framework": null }, "subkind": "primary", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:19.447+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "30f147d9-11a4-4a1b-8342-7592fc7dad75", "parentComponentId": null }, { "bbox": null, "kind": "callout", "text": "FDA quotes the EMA's criticism of HARMONY 1-bis post-hoc analysis as unplanned, but gave a free pass", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": { "name": "Visual emphasis", "slug": "visual-emphasis", "status": "active", "bestFor": null, "canonId": "019dd9e1-474b-736b-a8eb-a794dd88241c", "version": 1, "bodyDocId": null, "description": "Drawing the eye to one element above the rest of the slide.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:43+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d1-73a9-abb6-d90d310712b8", "parentComponentId": null }, { "bbox": null, "kind": "metric", "text": "p-value: 0.030", "attrs": null, "canon": { "kind": { "name": "Metric", "slug": "metric", "status": "active", "canonId": "019de52c-f923-73bf-8081-d0b1a8c5264d", "version": 1, "description": "Big-number or KPI value." }, "tool": { "name": "Quantification", "slug": "quantification", "status": "active", "bestFor": null, "canonId": "019dd9e1-47ab-72ce-a079-aab1f5299e88", "version": 1, "bodyDocId": null, "description": "Translating a claim into numbers, charts, or tables.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": "primary", "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:43+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d1-73a9-abb6-e3701510e998", "parentComponentId": null }, { "bbox": { "h": 0.22, "w": 0.86, "x": 0.07, "y": 0.72 }, "kind": "paragraph", "text": "“According to EMA Public Assessment Report analysis of the primary efficacy data by “artificially clustering” small clinical study centers, the mean ESS decrease with pitolisant showed statistically significant improvement compared to placebo (-2.19; 95% CI (-4.17, -0.22); p 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The EMA report stated pooling of centers was not pre-planned. In contrast, the SAP which was issued a month (February 13, 2013) before the database lock (March 13, 2013) included an Appendix (see Figure 14 below) to display the random re-allocation of small centers into clusters. Analysis conducted without re-allocation of small study centers showed that pitolisant didn’t demonstrate statistically significant separation from placebo (-1.94; 95% CI (-4.05, 0.07); p = 0.065). In clarifying FDA request, the applicant made clear (April 25, 2019) that the SAP for the study was amended prior to unblinding of the study.”", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:19.447+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "25f1b76a-259f-427b-b589-228a7d954641", "parentComponentId": null }, { "bbox": { "h": 0.08, "w": 0.86, "x": 0.07, "y": 0.62 }, "kind": "paragraph", "text": "Of note, the EMA Public Assessment Report stated that clustering of small clinical study centers was not pre-planned and that results on the primary endpoint would not be significant without clustering of these centers. The Applicant clarified in a response to an information request that the clustering was in fact pre-planned. Further details, as provided in the biometrics review, are as follows:", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:19.447+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "a58496d3-0dba-41dd-9a1d-28753e5fac08", "parentComponentId": null }, { "bbox": { "h": 0.45, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "The next pivotal RCT after HARMONY 1 was HARMONY 1-bis. It was a flop and never published, but the EMA and FDA review documents contain telling details. The design was similar to HARMONY 1 – 8 weeks duration with pitolisant compared to placebo and modafinil with ESS again as the primary endpoint. Pitolisant showed an irrelevant -2.19 reduction in ESS vs. placebo, which Harmony claimed was statistically significant with p=0.030 – but only after an unplanned post-hoc clustering of “small clinical study centers,” without which the ESS reduction would have been -1.94 and not stat sig (p=0.065). And the daily cataplexy rate on pitolisant actually doubled from 0.84 at baseline to 1.69. Nonetheless, the FDA viewed the trial as evidence of efficacy, once again illustrating the glaring deficiencies of the accelerated approval pathway. The FDA summarized the EMA review which criticized the “artificial” clustering as unplanned, but then simply gave Harmony a free pass: “The Applicant clarified in a response to an information request that the clustering was in fact pre-planned.”", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:19.447+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "a5f7e457-39a6-4555-a2e6-06401cd55ca1", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "The Applicant clarified in a response to an information request that the clustering was in fact pre-planned. — FDA", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:43+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d1-73a9-abb6-de7d91f2be58", "parentComponentId": null }, { "bbox": { "h": 0.02, "w": 0.45, "x": 0.07, "y": 0.95 }, "kind": "source-note", "text": "Source: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/211150Orig2s000MedR.pdf", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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HARMONY I-BIS", "attrs": null, "canon": { "kind": { "name": "Image", "slug": "image", "status": "active", "canonId": "019de52c-f978-701f-a720-51d029d769e7", "version": 1, "description": "Photo, illustration, screenshot or icon." }, "tool": null, "subkind": { "name": "Screenshot", "slug": "screenshot", "status": "active", "canonId": "019de52c-fd87-7509-8391-3d79fb339379", "version": 1, "description": null }, "framework": null }, "subkind": "screenshot", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:17.862+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "33a32026-a2d5-478b-8e6b-bdf2039fbbc4", "parentComponentId": null }, { "bbox": { "h": 0.35, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "The FDA blithely accepted Harmony’s explanation that the 1-bis Statistical Analysis Plan issued a month before database lock included an appendix to display the clustering, and took at face value that this plan was “amended prior to unblinding of the study.” The FDA then shows the Statistical Analysis Plan in a table, but it is entirely redacted - presumably at Harmony’s request. We are troubled that something so innocuous would be redacted - on top of the fact that the data was never published in a paper - and are curious what Harmony was so worried about. The EMA review makes no mention of this purported pre-specified Statistical Analysis Plan and bluntly states it was “not pre-planned analysis.” If this plan existed, it would have been provided to the EMA as well and the review would have noted it.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:17.862+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "60372ab1-f6d0-4624-8a13-a096dfd744ad", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "“amended prior to unblinding of the study.” — Harmony Biosciences (as cited by Scorpion Capital)", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:51+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d1-73a9-abba-ebff9f4e896c", "parentComponentId": null }, { "bbox": { "h": 0.02, "w": 0.45, "x": 0.07, "y": 0.95 }, "kind": "source-note", "text": "Source: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/211150Orig2s000MedR.pdf", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. Numbered footnotes use attrs.numbered." }, "tool": null, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:17.862+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "1479a2bb-7536-484c-a43a-4f264eeac0b3", "parentComponentId": null }, { "bbox": { "h": 0.02, "w": 0.25, "x": 0.07, "y": 0.92 }, "kind": "source-note", "text": "Source – Statistical Analysis Plan, HARMONY I-BIS, page 11", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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uses a 'villain' framing for the FDA reviewer's oversight.", "function": "expose_contradiction", "rawType": "expose_contradiction", "block": null, "metadata": { "slideType": "expose_contradiction", "slideTypeCanon": { "name": "Expose contradiction", "slug": "expose_contradiction", "status": "active", "canonId": "019de52d-124c-75aa-984a-0a3d0d8fc8df", "version": 1, "description": null }, "function": "expose_contradiction", "functionCanon": { "name": "Expose contradiction", "slug": "expose_contradiction", "status": "active", "canonId": "019de52d-171f-776f-887c-73edaff4cf9c", "version": 1, "description": null }, "density": "overcrowded", "densityScore": 77, "componentCount": 8, "textChars": 3010, "nDataPoints": 6, "notes": "The slide uses a 'villain' framing for the FDA reviewer's oversight.", "elementsJson": [ "paragraph", "footnote" ], "confidence": 0.95, "extraction": { "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "at": "2026-05-02 20:18:18.957+00", "seconds": 4.065, "promptVersion": "v2-canon-conditioned" } }, "links": { "slide": "/slides/019dd923-622c-750b-8b9a-21918ac10c17/231", "deck": "/decks/019dd923-622c-750b-8b9a-21918ac10c17", "deckAnchor": "/decks/019dd923-622c-750b-8b9a-21918ac10c17#slide-231", "deckJson": "/decks/019dd923-622c-750b-8b9a-21918ac10c17.json" }, "components": [ { "bbox": { "h": 0.03, "w": 0.79, "x": 0.07, "y": 0.7 }, "kind": "callout", "text": "However, FDA reviewer missed the forest for the trees and viewed it as evidence of efficacy", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": null, "subkind": { "name": "Primary callout", "slug": "primary", "status": "active", "canonId": "019de52c-fbd1-70eb-a9ce-8997f8674c1d", "version": 1, "description": null }, "framework": null }, "subkind": "primary", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:18.957+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "9d58d1ee-de4e-4cb2-8c2d-a799608a4ebe", "parentComponentId": null }, { "bbox": { "h": 0.03, "w": 0.55, "x": 0.07, "y": 0.47 }, "kind": "callout", "text": "EMA rejects HARMONY 1-bis EDS score reduction as clinically immaterial", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": null, "subkind": { "name": "Primary callout", "slug": "primary", "status": "active", "canonId": "019de52c-fbd1-70eb-a9ce-8997f8674c1d", "version": 1, "description": null }, "framework": null }, "subkind": "primary", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:18.957+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "a25ad727-fa07-4684-b70c-a2b9fb978ff2", "parentComponentId": null }, { "bbox": null, "kind": "callout", "text": "The FDA’s reviewer’s conclusion – shown below – exhibits no awareness that a 2 point reduction in ESS is a failure: “HARMONY 1-bis provides confirmatory evidence of pitolisant’s effect on EDS.”", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": { "name": "Visual emphasis", "slug": "visual-emphasis", "status": "active", "bestFor": null, "canonId": "019dd9e1-474b-736b-a8eb-a794dd88241c", "version": 1, "bodyDocId": null, "description": "Drawing the eye to one element above the rest of the slide.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:43+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d1-73a9-abb7-1130ca0be727", "parentComponentId": null }, { "bbox": { "h": 0.38, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "The EMA noted that the clustering was ultimately irrelevant, as even after using it the ESS reduction barely improved from -1.94 to -2.19. Although this drove the p-value from non-stat sig (p=.07) to stat sig (p=.03), the reduction “was clinically not relevant in both analyses.” In contrast, the FDA missed the forest for the trees and used the 1-bis trial along with HARMONY 1 as sufficient to show efficacy in EDS. Even the HARMONY 1 paper as well as the protocol for HARMONY 1-bis stated that the clinically relevant threshold is 3 points, as the EMA repeats: “This difference was not clinically relevant as it was lower than the pre-defined threshold of 3 points.” The FDA’s reviewer’s conclusion – shown below – exhibits no awareness that a 2 point reduction in ESS is a failure:” “HARMONY 1-bis provides confirmatory evidence of pitolisant’s effect on EDS.”", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:18.957+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "2cef3c19-3ac6-4976-a784-38f958fd0117", "parentComponentId": null }, { "bbox": { "h": 0.16, "w": 0.71, "x": 0.07, "y": 0.51 }, "kind": "paragraph", "text": "According to the pre-specified minimal clinically relevant difference in both pivotal studies, pitolisant showed an improvement on the ESS final score compared to placebo only in Harmony I study (-3.3 points), but not in Harmony Ibis (-2.19 points, with small centres re-allocation and -1.94 points with original centres). The effect of clustering did not improve the modest effect of pitolisant on ESS changes (-1.94 versus 2.19) in Harmony Ibis as it was clinically not relevant in both analysis. However, the clustering artificially improved the p value, from non-significant (p=0.07) to significant (p=0.03).", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:18.957+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "5dd2bbe5-b952-475a-b086-39cdc161df6d", "parentComponentId": null }, { "bbox": { "h": 0.21, "w": 0.62, "x": 0.07, "y": 0.74 }, "kind": "paragraph", "text": "Reviewer comment: HARMONY 1-bis provides confirmatory evidence of pitolisant’s effect on EDS. This study demonstrated efficacy on the primary endpoint, the ESS. However, when results of the MWT, an objective measure of EDS, were analyzed using the statistical test that was prespecified in the analysis plan, the results were not significant. The CGI-C results suggest that pitolisant had a clinically meaningful effect on EDS, though the study did not detect a difference in quality of life scores or overall opinion on treatment in pitolisant-treated patients. No effect on daily rates of cataplexy was found in this study. 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"extraction": { "at": "2026-05-02 20:18:18.993+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "ddce5388-bd7e-4303-81a4-d9ab13403341", "parentComponentId": null }, { "bbox": null, "kind": "callout", "text": "In addition, HARMONY 1-bis displays all the other red flags as HARMONY 1: questionable foreign jurisdictions, with 40% of trial patients in Hungary and Argentina; pitolisant patients continued taking concomitant narcolepsy medications, creating a confounding factor; dose response data is again withheld, even though dosing was all over the place with 24% of patients on 10mg and 63% on 20mg; protocol violations and amendments, such as what appears to be another trial-size expansion, which the EMA review alludes to with no detail.", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, 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"subkind": { "name": "Pie chart", "slug": "pie", "status": "active", "canonId": "019de52c-ffdb-71bb-a800-5c5ab9f1c373", "version": 1, "description": null }, "framework": null }, "subkind": "pie", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:18.993+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "9cd0a4c1-69cd-4ca9-aa13-7d23d88635c4", "parentComponentId": null }, { "bbox": { "h": 0.03, "w": 0.9, "x": 0.05, "y": 0.95 }, "kind": "source-note", "text": "Source: https://www.accessdata.fda.gov/drugsatsfda_docs/nda/2021/211150Orig2s000MedR.pdf; https://www.ema.europa.eu/en/documents/assessment-report/wakix-epar-public-assessment-report_en.pdf", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide 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HARMONY CTP (P11-05)", "attrs": null, "canon": { "kind": { "name": "Chart", "slug": "chart", "status": "active", "canonId": "019de52c-f9a0-76ef-adc6-0b859109d1f8", "version": 1, "description": "Quantitative chart." }, "tool": null, "subkind": { "name": "Pie chart", "slug": "pie", "status": "active", "canonId": "019de52c-ffdb-71bb-a800-5c5ab9f1c373", "version": 1, "description": null }, "framework": null }, "subkind": "pie", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:19.438+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "ca7fbd61-da4b-42a1-9e54-7a560987e137", "parentComponentId": null }, { "bbox": null, "kind": "metric", "text": "study participants by country: 38%", "attrs": null, "canon": { "kind": { "name": "Metric", "slug": "metric", "status": "active", "canonId": "019de52c-f923-73bf-8081-d0b1a8c5264d", "version": 1, "description": "Big-number or KPI value." }, "tool": { "name": "Quantification", "slug": "quantification", "status": "active", "bestFor": null, "canonId": "019dd9e1-47ab-72ce-a079-aab1f5299e88", "version": 1, "bodyDocId": null, "description": "Translating a claim into numbers, charts, or tables.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": "primary", "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:43+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d1-73a9-abb7-2f07d23c5481", "parentComponentId": null }, { "bbox": { "h": 0.42, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "At the point that CTP was conducted, Bioprojet was on thin ice and in need of more convincing data – pitolisant barely reduced ESS scores in HARMONY 1 and showed modafinil to be markedly inferior, and failed to show statistical significance in cataplexy in the absence of post-hoc data games. HARMONY 1-bis results were even worse. The CTP trial was Bioprojet’s last shot and Hail Mary. We think they took no chances and picked trial sites in low-quality foreign jurisdictions where they could simply pay for the results they needed. CTP included no Western European countries: 38% of study participants were in Russia, which along with Ukraine, Turkey, Serbia and Hungary comprised ~90% of patients, in addition to Bulgaria, Poland, Macedonia, and the Czech Republic. 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Now, a new paper published in the New England Journal of Medicine has provided “smoking gun”", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:20.705+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "5c4dd9f9-ba38-4c92-ad8d-71dc5b0ac4d6", "parentComponentId": null }, { "bbox": { "h": 0.45, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "Recent studies have sounded warning bells about fraud and integrity issues in foreign trials especially in Eastern Europe, Russia, and other locations which played an oversized role in the pitolisant trials, particularly HARMONY CTP – “results from sites in Russia...cannot be trusted.” FDA Commissioner Robert Califf commented on similar findings published in the New England Journal of Medicine as “disturbing and it’s good to get it published...offshoring for financial reasons is bad because it raises risk of malfeasance.” A Stanford professor published a paper demonstrating that foreign trials are biased to deliver positive results and questioned “how much we can trust clinical evidence from these settings.” Several studies note wholesale fraud in clinical trials conducted in Russia – in one case, trial personnel simply sold the drug in the open market and patients who supposedly were administered it never actually got it.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:20.705+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "c4a48151-2354-4a72-8083-8669d5ad911c", "parentComponentId": null }, { "bbox": { "h": 0.22, "w": 0.43, "x": 0.5, "y": 0.69 }, "kind": "paragraph", "text": "These numbers back up an earlier article which drew what has to be the most likely conclusion: that a significant number of patients in Russia and Georgia never ever got the drug. The Cardiobrief piece goes further, airing out the speculation that the spironolactone was, in fact, sold off on the open market by trial personnel rather than actually used as intended. That's the first thought that occurred to me, too - it had to go somewhere, right?", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:20.705+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "daa6f1d2-66f3-4946-ab94-fba06f85dce5", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "“results from sites in Russia...cannot be trusted.” — FDA Commissioner Robert Califf. “disturbing and it’s good to get it published...offshoring for financial reasons is bad because it raises risk of malfeasance.” — FDA Commissioner Robert Califf. “how much we can trust clinical evidence from these settings.” — Stanford professor.", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:44+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d1-73a9-abb7-902889045ce9", "parentComponentId": null }, { "bbox": { "h": 0.05, "w": 0.6, "x": 0.07, "y": 0.94 }, "kind": "source-note", "text": "Source: https://www.bmj.com/content/346/bmj.f707; http://www.cardiobrief.org/2017/04/26/serious-questions-raised-about-integrity-of-international-trials/; https://www.nejm.org/doi/full/10.1056/NEJmc1612601", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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and an ESS score reduction of -3.5 vs. placebo, better than the -2.4 in HARMONY 1 and no ESS effect in 1-bis. 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The key chart in the trial paper is highly misleading, using a log scale for the Y-axis to exaggerate separation vs. placebo, as it was minimal after the first two weeks.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:19.231+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "6f548e52-a35e-42fb-bcb9-fc8e9ccb1fb2", "parentComponentId": null }, { "bbox": { "h": 0.03, "w": 0.8, "x": 0.05, "y": 0.95 }, "kind": "source-note", "text": "Source: https://www.accessdata.fda.gov/drugs...", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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Patients reported in individual diaries all cataplexy attacks defined as sudden and transient episodes (ranging from several seconds to a few minutes) of partial or generalised loss of muscle tone triggered by emotion. For each patient, we calculated the final weekly cataplexy rate (WCRf) measured during week 4 of stable dose treatment, and the corresponding baseline rate (WCRb) measured during the 2 weeks preceding randomisation. 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The definition of cataplexy per the protocol was amorphous and open to extensive patient interpretation, particularly given the inclusion of partial cataplexy: “Patients reported in individual diaries all cataplexy attacks defined as sudden and transient episodes (ranging from several seconds to a few minutes) of partial or generalised loss of muscle tone triggered by emotion.” A patient could consider a brief jerk, twitch, blinking, grimace, or an emotional reaction as partial cataplexy, and could easily associate any body sensation as cataplexy during emotional triggers such as laughter, excitement, stress, or anger.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:25.98+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "80e5ab3c-adbe-458b-9b26-1958dd30ce5e", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "Patients reported in individual diaries all cataplexy attacks defined as sudden and transient episodes (ranging from several seconds to a few minutes) of partial or generalised loss of muscle tone triggered by emotion. — Study Protocol/Pubmed", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:44+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d1-73a9-abb7-ab7897e081b5", "parentComponentId": null }, { "bbox": { "h": 0.02, "w": 0.25, "x": 0.07, "y": 0.95 }, "kind": "source-note", "text": "Source: https://pubmed.ncbi.nlm.nih.gov/28129985/", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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The maximal dose received during the study was 36 mg / day in 85% of patients. After 12 months of treatment, improvements in EDS assessed by ESS score of remaining patients is of same magnitude as those observed in the other trials in narcoleptic patients. The decrease in mean ESS score (SD) was -3.62 (4.63) after 1 year. ESS score reduction lower than -4.6 in trial paper (excerpted in previous slide)", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:22.45+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "73547c51-6d64-40ea-8eb5-f0ac3535746c", "parentComponentId": null }, { "bbox": { "h": 0.35, "w": 0.86, "x": 0.07, "y": 0.2 }, "kind": "paragraph", "text": "HARMONY 3 calls into question the purported ESS reductions in the three principal trials in support of the pitolisant NDA (HARMONY 1, 1-bis, and CTP), as it was an open-label trial with a low bar given the subjective patient-reported ESS questionnaire, yet the ESS reductions were markedly lower than in the pivotal studies. A nugget buried in an appendix of the EMA review is even more damning, as it shows that most patients discontinue the drug. The HARMONY 3 paper states that 40% of de novo patients discontinued within months due to lack of efficacy. Data provided to the EMA – which the FDA never mentions – indicates the discontinuations only accelerate after year one. HARMONY 3 followed patients for 5 years, even though the trial paper (2019) fails to disclose this fact, and nor does it show any data beyond the first year, which we find troubling. The EMA states that of 102 patients at the start of HARMONY 3, 68 (67%) were left at 12 months, and only 44%, 37%, 33%, and 14% at years 2, 3, 4, and 5. 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There are almost no high volume prescribers of Wakix who are not paid speakers for Harmony, and even they are generally ambivalent about the drug. Some of the highest volume prescribers nationally - in the top ten - bluntly stated it doesn’t work.\n2. Wakix has a supernormal patient discontinuation rate of 30-100% - per individual data points from interviews - typically within weeks or months, due to lack of efficacy and/or side effects. Every single physician, including speakers, provided this color.\n3. Physicians generally don’t think Wakix has an effect, or at best an incremental one. Some speculated it’s simply a placebo response, with even the highest volume prescribers conveying the tone that “it’s better than nothing.”\n4. Essentially every physician – even among its most ardent “fans,” i.e., speakers – uses Wakix as a 3rd or 4th line drug as part of a cocktail, illustrating the widespread perception of its negligible value. Doctors emphasized it is not a monotherapy and that even Wakix reps only promote it as part of a combination.\n5. Wakix is a failed drug launch with no buzz or enthusiasm among sleep physicians, with even speakers saying that Harmony’s market opportunity is saturated, with usage peaking in 2022 and little growth remaining in terms of new patient starts or new prescribers.", "attrs": null, "canon": { "kind": { "name": "List", "slug": "list", "status": "active", "canonId": "019de52c-f94b-779b-a53b-fd4904a5f4d2", "version": 1, "description": "Bullet or numbered list." }, "tool": null, "subkind": { "name": "Numbered list", "slug": "numbered", "status": "active", "canonId": "019de52c-fcc0-7718-a284-a4250c805df2", "version": 1, "description": null }, "framework": null }, "subkind": "numbered", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:22.72+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "760d7d81-0266-49fd-8121-bed4f8bad005", "parentComponentId": null }, { "bbox": { "h": 0.15, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "We conducted interviews with 16 current and former prescribers of Wakix. We consulted a broad, geographically diverse panel across various practice settings, and specifically sought out a number of Harmony’s speakers and highest volume prescribers – we spoke with 6 of the top 10 recipients of payments from Harmony per the CMS OpenPayments database. 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New patient starts have plummeted, with one prescriber after another – even speakers – describing a fall-off in late 2021 to 2022, and the last 6 months in particular, as they simply ran out of narcoleptics to try it on.\n7. Wakix competes in a crowded field and other drugs work better. Physicians universally stated it is no better than standard of care and generics like modafinil. Doctors are far more excited about sodium oxybate (Xyrem, Xywav).\n8. Wakix is plagued by adverse effects and extensive drug-drug interactions, which contribute to its high discontinuation rate. Physicians narrated several serious adverse effects, including a hospitalization for long QT syndrome.\n9. Harmony’s sales and marketing messaging has created a false sense of safety and complacency among doctors, who appear to ignore the warnings on the label and generally don’t run tests or monitor patients. This dynamic was especially prevalent among its speakers and highest volume prescribers.\n10. 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Prescriber #2: KOL in Europe... Prescriber #3: Professor of neurology... Prescriber #4: Neurologist and professor...", "attrs": null, "canon": { "kind": { "name": "List", "slug": "list", "status": "active", "canonId": "019de52c-f94b-779b-a53b-fd4904a5f4d2", "version": 1, "description": "Bullet or numbered list." }, "tool": null, "subkind": { "name": "Bullet list", "slug": "bullet", "status": "active", "canonId": "019de52c-fc98-7169-a083-5cab805076ca", "version": 1, "description": null }, "framework": null }, "subkind": "bullet", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:21.696+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "c73c06a2-2a6f-48ca-9d80-e1272b8b3111", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "I don't hear about it much from my colleagues — Prescriber #1. I’m think I’m not alone in this opinion — Prescriber #2. there’s just not a lot pf open running room for Wakix in the setting of narcolepsy — Prescriber #3. weakest of all the drugs out there — Prescriber #4.", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:45+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d1-73a9-abb8-4e6e7236bf8f", "parentComponentId": null }, { "bbox": { "h": 0.03, "w": 0.3, "x": 0.07, "y": 0.95 }, "kind": "source-note", "text": "Source: Scorpion Capital consultation calls with experts", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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It's just part of the cocktail, and it's harmless", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": { "name": "Visual emphasis", "slug": "visual-emphasis", "status": "active", "bestFor": null, "canonId": "019dd9e1-474b-736b-a8eb-a794dd88241c", "version": 1, "bodyDocId": null, "description": "Drawing the eye to one element above the rest of the slide.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:46+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d1-73a9-abb8-dbd39ad46180", "parentComponentId": null }, { "bbox": { "h": 0.15, "w": 0.86, "x": 0.07, "y": 0.32 }, "kind": "list", "text": "Prescriber #6: Physician in private and academic practice in Philadelphia, large practice with five sleep doctors but only 5 Wakix patients among them. No new patient starts in 6 months; “I think that this drug is a little ‘meh’; no buzz or enthusiasm among sleep doctors; “I haven’t had a single patient who said, oh my god, this is so much better”; always part of a cocktail – “never been a first line and even the sales rep told me actually they didn’t promote it that way”; reimbursement pressure has “gotten tighter” in the last 6 months.", "attrs": null, "canon": { "kind": { "name": "List", "slug": "list", "status": "active", "canonId": "019de52c-f94b-779b-a53b-fd4904a5f4d2", "version": 1, "description": "Bullet or numbered list." }, "tool": null, "subkind": { "name": "Bullet list", "slug": "bullet", "status": "active", "canonId": "019de52c-fc98-7169-a083-5cab805076ca", "version": 1, "description": null }, "framework": null }, "subkind": "bullet", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:29.773+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "28573ead-9f36-4b28-a2e4-e08b49330561", "parentComponentId": null }, { "bbox": { "h": 0.18, "w": 0.86, "x": 0.07, "y": 0.13 }, "kind": "list", "text": "Prescriber #5: Neurologist in private practice in New York with 70-80 narcolepsy patients. Has 15-20 patients on Wakix, the most we encountered by a non-speaker for Harmony, of which half have discontinued; third or fourth line medication in a crowded field; doesn’t even think it works and dispenses it just to offer patients something – “I know it doesn’t fully work. It’s just part of the cocktail, and it’s harmless”; reimbursement is “harrowing...it’s a bunch of hurdles”; no buzz in the field and “a lot of doctors think it’s a waste of money”; partner in his practice won’t prescribe it as he doesn’t “think it works at all.”", "attrs": null, "canon": { "kind": { "name": "List", "slug": "list", "status": "active", "canonId": "019de52c-f94b-779b-a53b-fd4904a5f4d2", "version": 1, "description": "Bullet or numbered list." }, "tool": null, "subkind": { "name": "Bullet list", "slug": "bullet", "status": "active", "canonId": "019de52c-fc98-7169-a083-5cab805076ca", "version": 1, "description": null }, "framework": null }, "subkind": "bullet", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:29.773+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "bc74658b-ba4a-42f4-8abf-8028ceddce48", "parentComponentId": null }, { "bbox": { "h": 0.2, "w": 0.86, "x": 0.07, "y": 0.71 }, "kind": "list", "text": "Prescriber #8: Private practice doctor in Alabama who states he may be Harmony’s top prescriber in the US with 100 patients on Wakix, and that he’s one of their top speakers and “has played a big role personally” in educating doctors nationally about the drug. “Aggressive” in offering Wakix to every narcoleptic, yet indicated the drug is not “a game changer,” with merely a subtle effect at best and is only “adjunctive” on top of a cocktail of other drugs. Thinks Harmony’s market opportunity is saturated and Wakix growth will be limited from here. States he’s so unconcerned about side effects that he doesn’t run any lab work – “I do not run EKG’s”; “I don’t check lab work” – and that he has no idea how much the drug costs.", "attrs": null, "canon": { "kind": { "name": "List", "slug": "list", "status": "active", "canonId": "019de52c-f94b-779b-a53b-fd4904a5f4d2", "version": 1, "description": "Bullet or numbered list." }, "tool": null, "subkind": { "name": "Bullet list", "slug": "bullet", "status": "active", "canonId": "019de52c-fc98-7169-a083-5cab805076ca", "version": 1, "description": null }, "framework": null }, "subkind": "bullet", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:29.773+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "eda5838a-7eda-4089-93da-0b928c63e9d8", "parentComponentId": null }, { "bbox": { "h": 0.22, "w": 0.86, "x": 0.07, "y": 0.48 }, "kind": "list", "text": "Prescriber #7: Physician in the New York/CT area who is a speaker and one of Harmony’s highest volume prescribers, scaling patients right away after FDA approval. We note his atypical prescribing patterns and promotionalism versus physicians who are not speakers. Has ~100 active narcolepsy patients and has put a third on Wakix: “I really, really liked what I saw”; “I had no hesitation to use the medicine”; “it works really, really well.” Often uses it as a standalone medication, in contrast to all other doctors we spoke to – including other speakers, who only use it as 3rd or 4th line in a cocktail. However, he stated insurance has recently become onerous to the point it’s turning off prescribers: “it’s been harder...I’ve been writing more letters and appeals...pain in the ass to prescribe”; “the fellows...say...it’s just so much easier to prescribe modafinil.”", "attrs": null, "canon": { "kind": { "name": "List", "slug": "list", "status": "active", "canonId": "019de52c-f94b-779b-a53b-fd4904a5f4d2", "version": 1, "description": "Bullet or numbered list." }, "tool": null, "subkind": { "name": "Bullet list", "slug": "bullet", "status": "active", "canonId": "019de52c-fc98-7169-a083-5cab805076ca", "version": 1, "description": null }, "framework": null }, "subkind": "bullet", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:29.773+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "fa45841b-dfc0-44c8-9dc7-af7974c7e1e0", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "I know it doesn't fully work. It's just part of the cocktail, and it's harmless — Prescriber #5. I think that this drug is a little 'meh' — Prescriber #6. I haven't had a single patient who said, oh my god, this is so much better — Prescriber #6. it's been harder...I've been writing more letters and appeals...pain in the ass to prescribe — Prescriber #7. 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It's just part of the cocktail, and it's harmless”; reimbursement is “harrowing…it's a bunch of hurdles”; no buzz in the field and “a lot of doctors think it's a waste of money”; partner in his practice won't prescribe it as he doesn't “think it works at all.”", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:24.409+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "705fa43b-fa8e-470f-a9d6-1aa40afea795", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "Wakix has kind of been a crowded field of third-line therapies... There are four FDA-approved medications now for this indication. 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Is there any buzz about it?” A: “A lot of doctors think it's a waste of money...I think a lot of doctors are unfamiliar with it or not so excited about it. There's not so many subscribers of it, and I'm starting to think that some doctors also think that Xywav is it.” Q: “And what does your partner say about it?” A: “He doesn't think it works at all.” -Neurologist in New York with 70-80 narcolepsy patients", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": null, "subkind": { "name": "Testimonial", "slug": "testimonial", "status": "active", "canonId": "019de52c-fc21-71b6-9ac3-8266a64945e8", "version": 1, "description": null }, "framework": null }, "subkind": "testimonial", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:24.899+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "499396f7-1d0c-4c4d-a823-53bbca18e1bc", "parentComponentId": null }, { "bbox": { "x": 0.07, "y": 0.37 }, "kind": "quote", "text": "“So, most of the time, I would prefer to use the third-line treatment. They're just not going to get approved by insurance until I step edits or step through two other treatments...in the end, we get it approved for our patients. But it's harrowing. It's a bunch of hurdles.” -Neurologist in New York with 70-80 narcolepsy patients", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": null, "subkind": { "name": "Testimonial", "slug": "testimonial", "status": "active", "canonId": "019de52c-fc21-71b6-9ac3-8266a64945e8", "version": 1, "description": null }, "framework": null }, "subkind": "testimonial", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:24.899+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "b75cc2a0-a227-47b1-981b-bf5587d42d8c", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "A lot of doctors think it's a waste of money...I think a lot of doctors are unfamiliar with it or not so excited about it. 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As I said, I haven’t had a patient who said, oh my god, this is so much better. That’s the one I’m waiting for. I kind of almost want to see the webcast to see what the people who are being paid to do it, who are doctors say in their own experience because I’m just not having that” - Physician in private and academic practice in PA with 30-40 narcolepsy patients", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:25.45+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "76169c4d-719b-4dc1-b72d-8eb2c0d4ae16", "parentComponentId": null }, { "bbox": { "h": 0.2, "w": 0.86, "x": 0.07, "y": 0.68 }, "kind": "paragraph", "text": "Never been a first line drug; sales rep says only promoted as combo therapy\nQ: “What’s the longest you’ve had a patient on Wakix of the five?”\nA: “Probably two years.\nQ: “Is this part of a cocktail, or are they on the drug alone?\nA: “It was part of a cocktail, yeah. Usually, with cataplexy, they were on Xywav, and they were on Sunosi, and they were on Wakix, all three, actually. It was step up...I have to say it’s never been a first-line, and even the sales rep told me actually they didn’t promote it that way.” - Physician in private and academic practice in PA with 30-40 narcolepsy patients", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:25.45+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "ce568b58-ea0c-4a79-b455-95fdaa4fa931", "parentComponentId": null }, { "bbox": { "h": 0.25, "w": 0.86, "x": 0.07, "y": 0.24 }, "kind": "paragraph", "text": "Large practice with 5 docs but only 5 patients on Wakix; “meh” drug; no new starts in 6 months\nA: “I’ll just round off and say I have 40 people with narcolepsy, I think maybe 12 of them have cataplexy, and the vast majority don’t...I have about five patients on Wakix.... We have 3 pulmonologists and two neurologists. I even asked the one neurologist. But I can tell you the total number of Wakix among all five of us. It’s not a lot. It’s not as much as these other drugs. ..”\nQ: “When was the last time you had a new patient go on it? So, you’ve had five. When did you last write a script?”\nA: “Beginning of the summer, maybe. It may have been six months. Yeah, there has not been a new start...my daughter, I’ll ask - how was Pre-Algebra? She goes, “Meh.” Sometimes I think that this drug is a little “meh.” -Physician in private and academic practice in PA with 30-40 narcolepsy patients", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:25.45+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "dd16fcf9-07f6-481a-aca2-f7c80978ed1c", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "\"I think that this drug is a little 'meh'\" — Physician in private and academic practice in PA with 30-40 narcolepsy patients. \"I haven't had a single patient who said, oh my god, this is so much better\" — Physician in private and academic practice in PA with 30-40 narcolepsy patients. \"It was part of a cocktail, yeah. Usually, with cataplexy, they were on Xywav, and they were on Sunosi, and they were on Wakix, all three, actually. It was step up...I have to say it's never been a first-line, and even the sales rep told me actually they didn't promote it that way.\" — Physician in private and academic practice in PA with 30-40 narcolepsy patients.", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:47+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d1-73a9-abb9-3bc103ef4b2f", "parentComponentId": null }, { "bbox": { "h": 0.03, "w": 0.3, "x": 0.07, "y": 0.95 }, "kind": "source-note", "text": "Source: Scorpion Capital consultation calls with experts", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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No new patient starts in 6 months; “I think that this drug is a little ‘meh’; no buzz or enthusiasm among sleep doctors; “I haven’t had a single patient who said, oh my god, this is so much better”; always part of a cocktail – “never been a first line and even the sales rep told me actually they didn’t promote it that way”; reimbursement pressure has “gotten tighter” in the last 6 months.", "attrs": null, "canon": { "kind": { "name": "Title", "slug": "title", "status": "active", "canonId": "019de52c-f7dd-76d9-b848-b1f12bd85cf4", "version": 1, "description": "Slide title or headline." }, "tool": null, "subkind": { "name": "Headline", "slug": "headline", "status": "active", "canonId": "019de52c-fae1-7463-9a7c-d60668eced0d", "version": 1, "description": null }, "framework": null }, "subkind": "headline", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:25.45+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "62ac69ec-1e7c-492b-9af0-d4ca2a3cb4c8", "parentComponentId": null } ], "metrics": [], "tools": [], "frameworks": [], "arcBeats": [], "loops": [], "locked": true }, { "page": 263, "type": "evidence", "title": "The slide uses a Q&A format to highlight the tightening reimbursement environment for a specific drug.", "function": "illustrate_case", "rawType": "testimonial", "block": null, "metadata": { "slideType": "testimonial", "slideTypeCanon": { "name": "Testimonial", "slug": "testimonial", "status": "active", "canonId": "019de52d-0a2d-7782-8a48-7e84df92cc97", "version": 1, "description": null }, "function": "illustrate_case", "functionCanon": { "name": "Illustrate case", "slug": "illustrate_case", "status": "active", "canonId": "019de52d-13b4-772c-bb73-1873612a7463", "version": 1, "description": null }, "density": "balanced", "densityScore": 37, "componentCount": 5, "textChars": 1263, "nDataPoints": 0, "notes": "The slide uses a Q&A format to highlight the tightening reimbursement environment for a specific drug.", "elementsJson": [ "headline_text", "quote_block", "footnote" ], "confidence": 1, "extraction": { "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "at": "2026-05-02 20:18:25.057+00", "seconds": 3.209, "promptVersion": "v2-canon-conditioned" } }, "links": { "slide": "/slides/019dd923-622c-750b-8b9a-21918ac10c17/263", "deck": "/decks/019dd923-622c-750b-8b9a-21918ac10c17", "deckAnchor": "/decks/019dd923-622c-750b-8b9a-21918ac10c17#slide-263", "deckJson": "/decks/019dd923-622c-750b-8b9a-21918ac10c17.json" }, "components": [ { "bbox": null, "kind": "callout", "text": "Yes. I think over the last year. It seems like it's gotten tighter, yes", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": { "name": "Visual emphasis", "slug": "visual-emphasis", "status": "active", "bestFor": null, "canonId": "019dd9e1-474b-736b-a8eb-a794dd88241c", "version": 1, "bodyDocId": null, "description": "Drawing the eye to one element above the rest of the slide.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:47+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d1-73a9-abb9-49f0e3c279a3", "parentComponentId": null }, { "bbox": { "h": 0.25, "w": 0.86, "x": 0.07, "y": 0.17 }, "kind": "paragraph", "text": "Insurance become more difficult in last 6 months\nA: “It became a little more difficult to prescribe. It required a pre-auth. Usually, you filled out a form, and that was it. And now, there are things like, have you been on modafinil or armodafinil? You have to be on other generics first.”\nQ: “And when did you observe this change in the reimbursement climate? Was there a particular point in time?”\nA: “Six months ago, probably.”\nQ: “So, you think the reimbursement environment has tightened over the last six months?”\nA: “Yes. I think over the last year. It seems like it’s gotten tighter, yes” - Physician in private and academic practice in PA with 30-40 narcolepsy patients", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:25.057+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "5bb31aae-5a5d-4290-b421-5d9d6a3b75a8", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "“It became a little more difficult to prescribe. It required a pre-auth. 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Has ~100 active narcolepsy patients and has put a third on Wakix: “I really, really liked what I saw”; “I had no hesitation to use the medicine”; “it works really, really well.” Often uses it as a standalone medication, in contrast to all other doctors we spoke to – including other speakers, who only use it as 3rd or 4th line in a cocktail. 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I actually am very fortunate to know his wife, who is a [redacted] in the community. He's a really great guy. He's Johnny on the spot, calls me back anytime I need something. I mean, the guy is just over-the-top great. 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I'm a very persuasive speaker. I'm passionate about what I do...I'm very enthusiastic, and I can talk to the wall; I can talk to anybody. So, I try to bring a lot of excitement to the drug talks...and the drug reps have told me, hey, we're getting people to write the drug for us...you put somebody with an MD in front of them, oh, I'll listen to that. ... I think I've played a big role—I think I've played a role personally with education in the country because I feel like I've really spoken to so many providers that they listen. I think they do\".", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": null, "subkind": { "name": "Testimonial", "slug": "testimonial", "status": "active", "canonId": "019de52c-fc21-71b6-9ac3-8266a64945e8", "version": 1, "description": null }, "framework": null }, "subkind": "testimonial", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:25.235+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "ec4444fc-a198-4115-bde7-1fac52512c9e", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "I sought Harmony out and said, \"Hey, look, dude. I really want to represent you guys.... I'm a very persuasive speaker. 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It's a no-brainer. It's not even scheduled. So, I mean, to not think of Wakix is not malpractice, but it's absurd practice. 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It doesn't work that way. It's an adjunctive measure to get people to feel improvement that they say, yeah, you know what? I do feel some improvement, and I notice it even more when I don't take it.", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": { "name": "Visual emphasis", "slug": "visual-emphasis", "status": "active", "bestFor": null, "canonId": "019dd9e1-474b-736b-a8eb-a794dd88241c", "version": 1, "bodyDocId": null, "description": "Drawing the eye to one element above the rest of the slide.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:49+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d1-73a9-abba-2a19490be1c7", "parentComponentId": null }, { "bbox": { "h": 0.7, "w": 0.86, "x": 0.07, "y": 0.21 }, "kind": "paragraph", "text": "Doesn't even think the drug is a game-changer; just a subtle effect and \"adjunctive measure\"...", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:28.508+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "144bf693-95fb-422d-8cae-7fe8f08fd4cb", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "yeah, unfortunately, it doesn't make people be like, oh my god, it's a game changer. 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I'm board certified in neurology and sleep medicine in the U.S. I'm kind of similarly board-certified in the UK and in Europe in sleep medicine now. So, I initially used Wakix in the U.S. for probably about two or three years before I moved back. And then, I've also had experience in using it in the UK. 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One, because of headaches, or they just don't think it's doing anything. And a lot of these people are working, so they can't wait. You say give it three months to see the effect because it's continued improvement, and they just say, “Well, I'm working. I can't do this. I need something else now.” - Neurologist in the UK who also practiced in the US; used Wakix in both settings", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 21:26:50.107+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "db8c5087-6e30-428b-aac8-453841bca2a1", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "“it interacts with everything” — Neurologist in the UK who also practiced in the US; used Wakix in both settings", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-23 01:18:10+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-70f3-714d-84c6-71547759a431", "parentComponentId": null }, { "bbox": { "h": 0.02, "w": 0.25, "x": 0.07, "y": 0.95 }, "kind": "source-note", "text": "Source: Scorpion Capital consultation calls with experts", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. Numbered footnotes use attrs.numbered." }, "tool": null, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 21:26:50.107+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "7abd4d5e-06d2-4481-b7a7-480b09ab12e9", "parentComponentId": null }, { "bbox": { "h": 0.35, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "title", "text": "Prescriber #9: UK-based neurologist who has advised Harmony and until recently practiced in the US and used Wakix in both settings; long experience with the drug given involvement with the early access program. Now barely uses it with only 2 patients on drug; 80% discontinuation rate within 1-2 months; “failed drug” that never “really took off”; people “reluctant to use it”; last resort drug and “not aware of any high volume prescribers” - only dabblers, as institutions stopped using it; hasn’t come across a single doctor who raves about it. Lack of efficacy, drug-drug interactions, and side effects cause patients to discontinue. Drug-drug interactions are such a huge problem - “it interacts with everything” - that he advised Harmony they need a separate website to alert patients. Asked Harmony for data from the failed HARMONY 2 trial - which was swept under the rug - but was never given it.", "attrs": null, "canon": { "kind": { "name": "Title", "slug": "title", "status": "active", "canonId": "019de52c-f7dd-76d9-b848-b1f12bd85cf4", "version": 1, "description": "Slide title or headline." }, "tool": null, "subkind": { "name": "Headline", "slug": "headline", "status": "active", "canonId": "019de52c-fae1-7463-9a7c-d60668eced0d", "version": 1, "description": null }, "framework": null }, "subkind": "headline", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 21:26:50.107+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "e09922ec-53a2-4c8d-8ff0-675c5140c0f4", "parentComponentId": null } ], "metrics": [], "tools": [], "frameworks": [], "arcBeats": [], "loops": [], "locked": true }, { "page": 271, "type": "tension", "title": "The slide uses highlighted text to emphasize negative feedback from a key opinion leader.", "function": "expose_contradiction", "rawType": "nominee_bio", "block": null, "metadata": { "slideType": "nominee_bio", "slideTypeCanon": { "name": "Nominee bio", "slug": "nominee_bio", "status": "active", "canonId": "019de52d-1136-70ae-861a-f546f0c9d1ef", "version": 1, "description": null }, "function": "expose_contradiction", "functionCanon": { "name": "Expose contradiction", "slug": "expose_contradiction", "status": "active", "canonId": "019de52d-171f-776f-887c-73edaff4cf9c", "version": 1, "description": null }, "density": "balanced", "densityScore": 38, "componentCount": 7, "textChars": 697, "nDataPoints": 0, "notes": "The slide uses highlighted text to emphasize negative feedback from a key opinion leader.", "elementsJson": [ "paragraph", "quote_block", "footnote" ], "confidence": 1, "extraction": { "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "at": "2026-05-02 20:18:25.903+00", "seconds": 3.542, "promptVersion": "v2-canon-conditioned" } }, "links": { "slide": "/slides/019dd923-622c-750b-8b9a-21918ac10c17/271", "deck": "/decks/019dd923-622c-750b-8b9a-21918ac10c17", "deckAnchor": "/decks/019dd923-622c-750b-8b9a-21918ac10c17#slide-271", "deckJson": "/decks/019dd923-622c-750b-8b9a-21918ac10c17.json" }, "components": [ { "bbox": null, "kind": "callout", "text": "I don't know of any high volume prescribers of pitolisant, to be honest.", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": { "name": "Visual emphasis", "slug": "visual-emphasis", "status": "active", "bestFor": null, "canonId": "019dd9e1-474b-736b-a8eb-a794dd88241c", "version": 1, "bodyDocId": null, "description": "Drawing the eye to one element above the rest of the slide.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:49+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d1-73a9-abba-3b250b4a9f45", "parentComponentId": null }, { "bbox": { "h": 0.04, "w": 0.85, "x": 0.07, "y": 0.43 }, "kind": "paragraph", "text": "Last resort drug; docs don’t like it; haven’t found a single doc who raves about it", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:25.903+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "bbc5fce1-3fdb-4d8a-8b13-def92c649b54", "parentComponentId": null }, { "bbox": { "h": 0.04, "w": 0.85, "x": 0.07, "y": 0.72 }, "kind": "paragraph", "text": "Asked for Harmony 2 trial data and never got it – failed trial that was swept under the rug", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:25.903+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "d9560a93-ab1e-4e6f-b421-a9a24b9291d3", "parentComponentId": null }, { "bbox": { "h": 0.04, "w": 0.85, "x": 0.07, "y": 0.15 }, "kind": "paragraph", "text": "Failed drug that never “really took off”; people “reluctant to use it”; “not aware of any high volume prescribers,”", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:25.903+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "e95a601c-efbe-45c6-aead-1cf11f9168ef", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "I don't think pitolisant ever really took off, to be honest. People seemed to be a bit reluctant to use it for whatever reason. — UK-based neurologist", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:49+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d1-73a9-abba-3fffd5f24bd7", "parentComponentId": null }, { "bbox": { "h": 0.02, "w": 0.3, "x": 0.07, "y": 0.95 }, "kind": "source-note", "text": "Source: Scorpion Capital consultation calls with experts", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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Because it interacts with everything.", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": { "name": "Visual emphasis", "slug": "visual-emphasis", "status": "active", "bestFor": null, "canonId": "019dd9e1-474b-736b-a8eb-a794dd88241c", "version": 1, "bodyDocId": null, "description": "Drawing the eye to one element above the rest of the slide.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-23 01:18:10+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-70f3-714d-84c6-89fdf728447d", "parentComponentId": null }, { "bbox": { "h": 0.06, "w": 0.85, "x": 0.07, "y": 0.19 }, "kind": "paragraph", "text": "Q: \"I think, you had said that at one point, you had as many as 10, and now you have a lot less. Why is that?\"\nA: \"People discontinue it for side effects or lack of efficacy or what is perceived as efficacy, I should say.\"", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:27.956+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "2757b800-cf2c-4305-aee0-3e681392531c", "parentComponentId": null }, { "bbox": { "h": 0.16, "w": 0.85, "x": 0.07, "y": 0.78 }, "kind": "paragraph", "text": "Q: \"So, headaches with stimulants, and what happens with SSRIs? I think it increases the concentration of the drug.\"\nA: \"It depends on which medication we're talking about. Sometimes it increases it; sometimes, it decreases it because they work through different cytochrome P450 enzymes. But again, the most common side effect of all that will be a headache because it just drives monoamines. What they were doing when I left was that I advised the company that they should really have a website where you can—like drugs.com—where you can put in the drug that the patient may be on so that you can give advice about how it interacts rather than trying to figure it out yourself.\"\nQ: \"So, you're saying that the drug-drug interactions were so significant that you thought the company should have a separate website for people? \"\nA: \"Yeah, absolutely. Because it interacts with everything.\" – Neurologist in the UK who also practiced in the US; used Wakix in both settings", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:27.956+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "412f5e6c-c486-49af-be92-ac9588dd999e", "parentComponentId": null }, { "bbox": { "h": 0.06, "w": 0.85, "x": 0.07, "y": 0.66 }, "kind": "paragraph", "text": "Q: \"Let's walk through each of those different drug-drug interactions. If they're on a stimulant and they take pitolisant, they get headaches that are bad enough where they discontinue?\"\nA: \"Yes. That is my common experience of this. The headaches are the biggest limiting factor to this.\"", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:27.956+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "53349aeb-21a6-40e8-8fe0-f6f3c3e4c09c", "parentComponentId": null }, { "bbox": { "h": 0.06, "w": 0.85, "x": 0.07, "y": 0.55 }, "kind": "paragraph", "text": "Q: \"So, you have issues if you take it with an SSRI? You have issues if you take it with a stimulant. You have issues if you take it with birth control.\"\nA: \"[Chuckles] Basically, yeah.\" – Neurologist in the UK who also practiced in the US; used Wakix in both settings", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:27.956+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "6bad8300-63d6-4b01-abb3-3835d54b3cf6", "parentComponentId": null }, { "bbox": { "h": 0.02, "w": 0.65, "x": 0.07, "y": 0.16 }, "kind": "paragraph", "text": "Lack of efficacy, drug-drug interactions, and major side effects that cause discontinuation", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:27.956+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "a538b5db-d4a4-4e18-9744-5cfd9ce29ed4", "parentComponentId": null }, { "bbox": { "h": 0.04, "w": 0.85, "x": 0.07, "y": 0.73 }, "kind": "paragraph", "text": "Q: \"And what percentage of patients are typically on stimulants? Most of them because they need to stay awake?\"\nA: \"It wasn't first-line when I was there, so they had to have tried stimulants before they could get pitolisant.\"", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:27.956+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "c141ac8e-0e5a-4594-a007-38542fdab9e6", "parentComponentId": null }, { "bbox": { "h": 0.02, "w": 0.5, "x": 0.07, "y": 0.63 }, "kind": "paragraph", "text": "Drug-drug interactions very prevalent – \"it interacts with everything\"", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:27.956+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "f0c8084a-3249-4fca-941b-4c979cf31ddb", "parentComponentId": null }, { "bbox": { "h": 0.28, "w": 0.85, "x": 0.07, "y": 0.26 }, "kind": "paragraph", "text": "Q: \"Talk to me about both of those: discontinuation rates, lack of efficacy, and side effects. What have you observed? When do they happen? How significant are they, etc.?\"\nA: \"In the U.S., I had early access to the drug before it was approved. So, we used it I quite a few patients then. The problem with the medication—it's very interesting because it's a new mechanism of action; there's nothing like that. So, that's quite exciting to think about from that approach. But it has drug-drug interactions, and that makes it much more complicated to use because a lot of these individuals have mental health issues as well, like anxiety/depression, so they're on SSRIs, SNRIs, and they interact with the medication. So, that's one problem. The other issue is that a lot of them are not naïve to the medication; they've tried other things, which, in my experience, if you add it in when people are on stimulants, a wake-promoting agent, they have headaches, and the headaches are quite significant that it makes them discontinue. So, that's one thing. The other issue it interacts with the birth control. Oral contraceptives. So, if they contain estrogen, that's an issue as well; it interacts with that drug.\"", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:27.956+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "f3fb93fe-5061-4174-89c0-656dde27a633", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "People discontinue it for side effects or lack of efficacy or what is perceived as efficacy, I should say. — Neurologist in the UK who also practiced in the US; used Wakix in both settings", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-23 01:18:10+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-70f3-714d-84c6-8d668cb323ad", "parentComponentId": null }, { "bbox": { "h": 0.02, "w": 0.3, "x": 0.07, "y": 0.95 }, "kind": "source-note", "text": "Source: Scorpion Capital consultation calls with experts", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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new starts have dropped in last 6 months; saturated field; reimbursement hassles; no better than standard of care with generics like modafinil", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:31.074+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "55e1da7c-18bc-43ef-b943-989a52ec7808", "parentComponentId": null }, { "bbox": { "h": 0.15, "w": 0.86, "x": 0.07, "y": 0.15 }, "kind": "paragraph", "text": "Has now soured – “I was very excited initially based on the mechanism of action” – but has barely put any patient on in the last 6 months. “Pretty high” discontinuation rate – “a lot of patients just don’t want to stay on it.” Competes in “a pretty saturated field” of EDS and cataplexy drug and no better than “the current standard of care” with inexpensive generics like modafinil. Onerous to prescribe given reimbursement pressure and her “staff was spending a lot of time in that regard.”", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:31.074+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "aaf9a5fd-f7e6-480d-aaf5-2a12835d728d", "parentComponentId": null }, { "bbox": { "h": 0.06, "w": 0.86, "x": 0.07, "y": 0.51 }, "kind": "paragraph", "text": "Q: “How many narcolepsy EDS patients do you have in total? What percentage of them do you have on Wakix?” A: “I’d say probably about 100-120 patients with narcolepsy, EDS, and cataplexy. So maybe 10% or 15% on.”", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:31.074+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "f750de42-e187-46f7-ab23-255e5299a7cf", "parentComponentId": null }, { "bbox": { "h": 0.12, "w": 0.86, "x": 0.07, "y": 0.38 }, "kind": "quote", "text": "A: “I would say Wakix right now is probably about 20 patients. I was very excited initially based on the mechanism...but I have to say it's a pretty saturated field... I might have had a couple more patients on over the past six months or so.”", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": null, "subkind": { "name": "Testimonial", "slug": "testimonial", "status": "active", "canonId": "019de52c-fc21-71b6-9ac3-8266a64945e8", "version": 1, "description": null }, "framework": null }, "subkind": "testimonial", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:31.074+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "3009cdef-5a8c-44d5-a2e4-ec57fd94d328", "parentComponentId": null }, { "bbox": { "h": 0.25, "w": 0.86, "x": 0.07, "y": 0.65 }, "kind": "quote", "text": "A: “I think it's gone down a little bit... I think, again, it was, well, number one, prescribing itself was just difficult in terms of access... my staff was spending a lot of time in that regard. I don't think it was better than the current standard of care... efficacy really wasn't better than the current standard of care.”", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": null, "subkind": { "name": "Testimonial", "slug": "testimonial", "status": "active", "canonId": "019de52c-fc21-71b6-9ac3-8266a64945e8", "version": 1, "description": null }, "framework": null }, "subkind": "testimonial", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:31.074+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "6c21b29f-0d18-4366-905c-69b59cf21750", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "I was very excited initially based on the mechanism...but I have to say it's a pretty saturated field...I might have had a couple more patients on over the past six months or so. — Neurologist in the New York, major academic center", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-23 01:18:10+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-70f3-714d-84c6-a712da74ff8d", "parentComponentId": null }, { "bbox": { "h": 0.02, "w": 0.3, "x": 0.07, "y": 0.95 }, "kind": "source-note", "text": "Source: Scorpion Capital consultation calls with experts", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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It's about 25% to 30%. Again, it's not a drug that works right away, so a lot of these patients they're not de novo; they've been on drugs that work much more quickly, some of the SNRIs that we use, some of the amphetamines, things like that. You have to counsel patients. Maybe at two months, you might see a benefit, maybe three months. 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"019de52c-f94b-779b-a53b-fd4904a5f4d2", "version": 1, "description": "Bullet or numbered list." }, "tool": null, "subkind": { "name": "Bullet list", "slug": "bullet", "status": "active", "canonId": "019de52c-fc98-7169-a083-5cab805076ca", "version": 1, "description": null }, "framework": null }, "subkind": "bullet", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:27.516+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "4ffee347-e511-47c2-a9ec-f0c4ce64e338", "parentComponentId": null }, { "bbox": { "h": 0.03, "w": 0.86, "x": 0.07, "y": 0.59 }, "kind": "list", "text": "50 Wakix patients out of 200 narcolepsy patients total", "attrs": null, "canon": { "kind": { "name": "List", "slug": "list", "status": "active", "canonId": "019de52c-f94b-779b-a53b-fd4904a5f4d2", "version": 1, "description": "Bullet or numbered list." }, "tool": null, "subkind": { "name": "Bullet list", 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Has a long history with Harmony, serving as a key trial investigator, adviser, and speaker. 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I personally attend to over 200 patients with narcolepsy... I have somewhere between 50 and 75 patients on Wakix, let's say 50, to be safe.", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": null, "subkind": { "name": "Testimonial", "slug": "testimonial", "status": "active", "canonId": "019de52c-fc21-71b6-9ac3-8266a64945e8", "version": 1, "description": null }, "framework": null }, "subkind": "testimonial", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:27.516+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "a160d4e1-34fb-447b-9b9c-5092598da67a", "parentComponentId": null }, { "bbox": { "h": 0.08, "w": 0.86, "x": 0.07, "y": 0.83 }, "kind": "quote", "text": "Out of the people I try it on, maybe 1 in 3 of them stop it. Most of the time, it's not side effects. Most of the time, I don't think it's doing anything... 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We had a large number of people started on in the trial. So, in terms of finding new patients and getting them either newly diagnosed or getting them switched over the therapy, I don't think it's going to ramp up by crazy amounts.”", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": null, "subkind": { "name": "Testimonial", "slug": "testimonial", "status": "active", "canonId": "019de52c-fc21-71b6-9ac3-8266a64945e8", "version": 1, "description": null }, "framework": null }, "subkind": "testimonial", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:29.066+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "23b45ecc-1b13-4146-ac14-c7a9317dd10d", "parentComponentId": null }, { "bbox": { "h": 0.15, "w": 0.86, "x": 0.07, "y": 0.26 }, "kind": "quote", "text": "Q: “When was the peak enthusiasm? Or is this still growing and getting better? Or did it peak and not it's kind of more tapered off?” A: “Enthusiasm from the medical community, you mean?...It did peak maybe like a year ago or so, but now I think it's tapered off a little bit. I think the biggest hurdle has been the whole insurance process of getting it, which is, a lot of the time, the hurdle for a lot of these practices. They don't want to do the extra work that's required to get the medication for their patients. I think that's a hurdle that limits enthusiasm.”", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": null, "subkind": { "name": "Testimonial", "slug": "testimonial", "status": "active", "canonId": "019de52c-fc21-71b6-9ac3-8266a64945e8", "version": 1, "description": null }, "framework": null }, "subkind": "testimonial", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:29.066+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "4421f1b0-e870-4e5c-8094-07bcae1d952d", "parentComponentId": null }, { "bbox": { "h": 0.28, "w": 0.86, "x": 0.07, "y": 0.64 }, "kind": "quote", "text": "Q: “Are there more high-volume prescribers that you think they're going to get? Or did they get them all right away? Could their growth be that they don't have a lot—they already got all the other doctors like you, the large sleep practices or are they still getting more of them? You can see what I'm trying to figure out. I'm just trying to figure out how saturated their growth could be. So, either you get more doctors or you get more patients per doctor. It sounds like there's only so much room in terms of patients per doctor. So, I can't imagine there are that many narcolepsy specialists out there.” A: “They're not, and, in my opinion, when a medicine like this first comes out, all the narcolepsy specialists gravitate to it. We like to try things. I think they probably have gotten the large majority of narcolepsy specialists out there, and I don't see them all of a sudden running into huge practices and taking over for—I don't see that happening. I have a feeling it's kind of saturated from that angle...I think most of the prescribers that are going to get on board are going to be these types of prescribers that are like onesies, twosies, threes—they're not going to be high-volume ones.” – Sleep physician in the Bay Area, CA", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": null, "subkind": { "name": "Testimonial", "slug": "testimonial", "status": "active", "canonId": "019de52c-fc21-71b6-9ac3-8266a64945e8", "version": 1, "description": null }, "framework": null }, "subkind": "testimonial", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:29.066+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "a4fd7ce6-7c7c-4389-b714-9e1b015fc2c8", "parentComponentId": null }, { "bbox": { "h": 0.12, "w": 0.86, "x": 0.07, "y": 0.42 }, "kind": "quote", "text": "Q: “And so, you have 110 on it now. How many do you think you're going to have on it next year? Do you think it's going to be steady at like 110, more or less, or is it going to go to like 150-200 over the next year or two?” A: “No, I don't think it's going to go up that much. Once they get the idiopathic hypersomnia, I might be able to use it more, but honestly, it'll probably go up to like 120-130, something like that.”", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": null, "subkind": { "name": "Testimonial", "slug": "testimonial", "status": "active", "canonId": "019de52c-fc21-71b6-9ac3-8266a64945e8", "version": 1, "description": null }, "framework": null }, "subkind": "testimonial", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:29.066+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "ea31a13a-f1e0-43c0-ac17-cadcf5289b12", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "They're not, and, in my opinion, when a medicine like this first comes out, all the narcolepsy specialists gravitate to it. 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I mean, we've always been told it's cheaper than Xywav. ... I have no idea how to get that information.", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": null, "subkind": { "name": "Pull quote", "slug": "pull-quote", "status": "active", "canonId": "019de52c-fbf9-76fe-97e1-a0b7540445c9", "version": 1, "description": null }, "framework": null }, "subkind": "pull-quote", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:28.258+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "4f5dc55b-65ca-422a-b4e4-742001d40b37", "parentComponentId": null }, { "bbox": { "h": 0.08, "w": 0.86, "x": 0.07, "y": 0.84 }, "kind": "quote", "text": "The biggest reimbursement hassle is you have to fail other medicines... and I think doctors, generally speaking, especially if they're not so interested or focused on narcolepsy, kind of give up.", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": null, "subkind": { "name": "Pull quote", "slug": "pull-quote", "status": "active", "canonId": "019de52c-fbf9-76fe-97e1-a0b7540445c9", "version": 1, "description": null }, "framework": null }, "subkind": "pull-quote", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:28.258+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "c39cb7c2-4c65-42ac-a098-a181c6660ab5", "parentComponentId": null }, { "bbox": { "h": 0.15, "w": 0.86, "x": 0.07, "y": 0.22 }, "kind": "quote", "text": "Those items are just warnings. You're not going to run into those issues hardly ever. I mean, to date, I've never ordered an EKG on a patient. That's what I tell doctors; these are just warnings.", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": null, "subkind": { "name": "Pull quote", "slug": "pull-quote", "status": "active", "canonId": "019de52c-fbf9-76fe-97e1-a0b7540445c9", "version": 1, "description": null }, "framework": null }, "subkind": "pull-quote", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:28.258+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "f70eef54-7d38-4e92-af35-4e9e39437929", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "“Those items are just warnings. 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"paragraph", "text": "Transcript of interview with the neurologist detailing the experience with Wakix, patient feedback, and reasons for discontinuation.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:31.521+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "fc9f9947-05bd-4309-b9ec-82ca8d706a98", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "\"recently I’ve stopped prescribing because it doesn’t really 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But I'd have to go back. I haven't actually looked at those original papers for a couple of years now...well, I remember it was not much. My clinical impression is that when it comes to efficacy, oxybates are stronger, and the oxybate trials generally showed a better separation from placebo in this regard. The higher dose was like 9 grams of oxybate per night, separate really well from placebo, and pitolisant didn't, and that's why...I do think it's...[chuckles]...I would like to think it's better than placebo, but I'd have to say I can't say that numerically I have much data to support that beyond what's in published papers.\" - -Neurologist and professor at a pre-eminent academic institution, advisor to Harmony", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:29.314+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "01d7c105-b0d8-4f75-9483-e94156e218a9", "parentComponentId": null }, { "bbox": { "h": 0.12, "w": 0.86, "x": 0.07, "y": 0.28 }, "kind": "paragraph", "text": "Large practice with >100 narcolepsy patients\n\"I'm a neurologist at a big Boston academic hospital. I only see sleep disorder patients, and my clinic is very skewed towards narcolepsy. I take care of more than 100 patients with narcolepsy. I also spend a lot of my time doing research on the basic mechanism through which drugs work in narcolepsy.\" -Neurologist and professor at a pre-eminent academic institution", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:29.314+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "120d291b-af4b-4c00-b430-0f77a73f0938", "parentComponentId": null }, { "bbox": { "h": 0.28, "w": 0.86, "x": 0.07, "y": 0.42 }, "kind": "paragraph", "text": "No better than generics like modafinil and worse than oxybates, so haven't used it in more than 10 patients; only a combo therapy\n\"I think pitolisant is a useful tool in our choice of medications that we use for treating narcolepsy. To really get to the bottom line, for what it delivers, I find it sort of annoyingly expensive. As a comparator, sodium oxybate and the low-sodium oxybate are also even more expensive, $150,000-plus per year. But they also can produce pretty high efficacy. Pitolisant is a well-tolerated drug, but its efficacy in my mind as far as treating sleepiness is not all that different than, say, modafinil. To be honest, I haven't actually used it in more than maybe 10 patients at this point. But my impression with most of them is that, yeah, it's helpful, but it doesn't really knock it out of the park. And so, I would say that's actually the biggest reason why I haven't prescribed it more is just because people say, yeah, it's okay, but they usually need something else on top of it...I can't think of a single patient where we've used Wakix as monotherapy.\" - -Neurologist and professor at a pre-eminent academic institution, advisor to Harmony", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:29.314+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "f4a967a6-6062-404c-9a86-defa9bbd812d", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "I can't think of a single patient where we've used Wakix as monotherapy. It's almost always in combination with other meds. — Neurologist and professor at a pre-eminent academic institution, advisor to Harmony", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-23 01:18:10+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-70f3-714d-84c7-0421daa85c6d", "parentComponentId": null }, { "bbox": { "h": 0.03, "w": 0.3, "x": 0.07, "y": 0.95 }, "kind": "source-note", "text": "Source: Scorpion Capital consultation calls with experts", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. Numbered footnotes use attrs.numbered." }, "tool": null, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:29.314+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "b4db9757-f3e5-4e1c-8ad3-dc69d8bf5d76", "parentComponentId": null }, { "bbox": { "h": 0.18, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "title", "text": "Prescriber #14: Neurologist and professor at a pre-eminent medical school, medical advisor to Harmony with a long relationship with the company. 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was keen to try it after reading the literature and doing research... -Neurologist at a large hospital system in a Midwest state", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:29.259+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "16b8ed5b-4940-4973-a5ab-2e6614339eb7", "parentComponentId": null }, { "bbox": { "h": 0.38, "w": 0.86, "x": 0.07, "y": 0.55 }, "kind": "paragraph", "text": "Only two of ten patients left on it due to QT issue with one patient, who was “a clean, healthy patient, no history of any cardiac issues or arrhythmia” Q: “When did you first prescribe it?” A: “Last year.” Q: “How many patients did you prescribe it to in total since then?” A: “About 10.” Q: “And how many are still on it?” A: “Two are still on it. The other 8, after having a discussion with them about the cardiac issue, they opted to stop taking it.” Q: “So, you had a conversation with the patients about the cardiac issue, and they decided to not take it anymore?” A: “That’s right. And this was, obviously, it was presented initially because it’s on the label. It was like, well, you know, there’s a small chance this could potentially happen. As with anything, we kind of looked it at as a very, very small chance, but I always tell the same patients as well that even if the risk of something is 0.01% when it happens to you, it’s 100%. So, your perspective on it kind of differs. Obviously, having a patient in the practice, you have that—even though we’re not certain, you know, like, yeah, we don’t know 100%, but this is a clean, healthy patient, no history of any cardiac issues or arrhythmia.” -Neurologist at a large hospital system in a Midwest state", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:29.259+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "85d94d27-cb66-4c3c-8f67-bfedf30c5f10", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "“I've got about, at this point, narcolepsy patients past and present are getting up to about—it came closer to 50-something patients. And the big issue, obviously, is the excessive daytime sleepiness in patients where it's interfering with normal activities and work, things like that. 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He was at dinner with his wife, and all of a sudden, he got diaphoretic, sweaty. Kind of said, I'm not feeling very good, clammy and diaphoretic. His wife happened to be a nurse. And she said, if you don't feel well, let's go home. So, on their way home, he was really just somnolent, not feeling good. They get home, and she happens to have a BP machine at home that also checks heart rate and sats. She checks it and his heart rate is just off, and she's checking his pulse, and it's irregular. And so, she's worried that he's having a heart attack. Obviously, she calls 911. They take him into the hospital, hook him up, and it's clear as day that he's got an arrhythmia, they thought maybe he was a-fib because his dad had a history of a-fib but upon further review by cardiology and electrophysiologist saw him, and they're like, oh yeah, he's got a long QT. And so, with the family history of a-fib, they're like, well, this is not a-fib. And they were going through all the medicines like that, anything new, medical history. They kind of said, hey, this is a newer medicine that you said. The cardiologist was pretty astute. He kind of looked up the info and said, hey, this medication can actually cause that, and I don't know necessarily that that's caused it, but certainly something to talk to your neurologist about. So, they work him up. He gets discharged and follows up with me. He's like, hey doc, this is what happened. And then I'm like, whoa, okay. In that case, the first thing is we're going to stop that medicine and see how things play out. So, obviously, we did.\"\nQ: \"And how long had the patient been on Wakix before this event occurred?\"\nA: \"He had been on it for 8 weeks, 2 months.\"\nQ: \"And what was the age of the patient?\"\nA: \"Forty-two. So, needless to say, it caused everybody to pay a little bit more attention.\"\nQ: \"At 42, was the person obese or had other cardiac morbidities? 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He was at dinner with his wife, and all of a sudden, he got diaphoretic, sweaty. Kind of said, I'm not feeling very good, clammy and diaphoretic. His wife happened to be a nurse. And she said, if you don't feel well, let's go home. So, on their way home, he was really just somnolent, not feeling good. They get home, and she happens to have a BP machine at home that also checks heart rate and sats. She checks it and his heart rate is just off, and she's checking his pulse, and it's irregular. And so, she's worried that he's having a heart attack. Obviously, she calls 911. They take him into the hospital, hook him up, and it's clear as day that he's got an arrhythmia, and they thought maybe he was a-fib because his dad had a history of a-fib but upon further review by cardiology and electrophysiologist saw him, and they're like, oh yeah, he's got a long QT. And so, with the family history of a-fib, they're like, well, this is not a-fib. And they were going through all the medicines like that, anything new, medical history. They kind of said, hey, this is a newer medicine that you said. The cardiologist was pretty astute. He kind of looked up the info and said, hey, this medication can actually cause that, and I don't know necessarily that that's what caused it, but certainly something to talk to your neurologist about. So, they work him up. He gets discharged and follows up with me. He's like, hey doc, this is what happened. And then I'm like, whoa, okay. In that case, the first thing is we're going to stop that medicine and see how things play out. 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The cardiologist wanted to get an echocardiogram to make sure the ejection fraction was standard. 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box." }, "tool": null, "subkind": { "name": "Primary callout", "slug": "primary", "status": "active", "canonId": "019de52c-fbd1-70eb-a9ce-8997f8674c1d", "version": 1, "description": null }, "framework": null }, "subkind": "primary", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:29.362+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "48c038b5-1a97-442d-863c-d74982ec0bc5", "parentComponentId": null }, { "bbox": null, "kind": "callout", "text": "Harmony’s sales and marketing for Wakix has one and only angle – that it is easier to prescribe because it’s not a controlled substance.", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": { "name": "Visual emphasis", "slug": "visual-emphasis", "status": "active", 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Given that Wakix is inferior to cheap generics like modafinil and physicians at best use it as a third or fourth line drug in cocktail, it has no other reason to exist. The DEA has classifies drugs from schedule 1 to 5, which creates certain requirements: 1) physicians have to be registered with the DEA In order to prescribe them; and 2) they can only write a scrip for 1-6 months of the drug, depending on its schedule level, which means their offices have to write scrips at regular intervals. Modafinil is schedule 4, which means a physician can write for a 6 month supply – making Wakix’s value proposition dubious. However, amphetamine-based stimulants for narcolepsy, like Adderall and Ritalin, are schedule 2, and doctors can only prescribe a 90-day supply at a time.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:29.362+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "3e586c0f-98ac-4573-b4e8-38df9f356179", "parentComponentId": null }, { "bbox": { "h": 0.02, "w": 0.3, "x": 0.07, "y": 0.91 }, "kind": "source-note", "text": "Source: https://en.wikipedia.org/wiki/Controlled_Substances_Act", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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We quote numerous doctors on the following pages who repeat the same refrain. One KOL said he sees \"absolutely no benefit from it\"; that \"it doesn't matter\"; and that \"I don't know what the big deal is.\" A Southern California specialist stated \"what kind of value is there? I don't see it.\"", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 21:26:53.44+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "46fe2e59-ef84-40cb-ad90-ffa4dc032328", "parentComponentId": null }, { "bbox": { "h": 0.2, "w": 0.86, "x": 0.07, "y": 0.68 }, "kind": "quote", "text": "Q: \"The company says this is not a scheduled drug. Is that really an advantage?\" A: \"...I prescribe a lot of scheduled... It's a little bit of a hassle... but at the same time... what type of value is there? What kind of value is there? I don't see it.\"", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": null, "subkind": { "name": "Testimonial", "slug": "testimonial", "status": "active", "canonId": "019de52c-fc21-71b6-9ac3-8266a64945e8", "version": 1, "description": null }, "framework": null }, "subkind": "testimonial", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 21:26:53.44+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "12140dea-41f9-4039-9b8d-4be7fc92512d", "parentComponentId": null }, { "bbox": { "h": 0.15, "w": 0.86, "x": 0.07, "y": 0.42 }, "kind": "quote", "text": "Q: \"One of the supposed advantages of Wakix is it's not a scheduled or controlled substance... Is there any big advantage...?\" A: \"...I don't think there's any big deal because, for me, I've still got to prescribe medicine, so I see absolutely no benefit from it.\"", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": null, "subkind": { "name": "Testimonial", "slug": "testimonial", "status": "active", "canonId": "019de52c-fc21-71b6-9ac3-8266a64945e8", "version": 1, "description": null }, "framework": null }, "subkind": "testimonial", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 21:26:53.44+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "ff103dd7-e8c8-4484-8eb0-e6b059652a71", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "“You know, sometimes, patients bring it up, but I don’t think there’s any big deal because, for me, I’ve still got to prescribe medicine, so I see absolutely no benefit from it.” — Neurologist who is a sleep specialist and professor at a leading institution; “What kind of value is there? 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How often does the patient—what is onerous about it being Schedule 3 or Schedule 4? What requirements does that involve?”\nA: “Not much. Schedule 3 and Schedule 4 can both be written with refills going as much as 6 months. My Xywav prescriptions, I have to refill twice a year, the same thing with modafinil. So, it’s not nearly as onerous as Adderall, where you have to write a new script every month...Schedule 2s are more annoying. Three and 4 are the same, honestly. It’s not that big a deal.”\nQ: “And most of the drugs in this category are Schedule 3 and 4? The common ones?”\nA: “All of the stimulants are Schedule 2. So, Schedule 3 is just Xyrem and Xywav, and Schedule 4 is modafinil, armodafinil, and Sunosi. All of the stimulants: Adderall, Vyvanse, and Ritalin, are all Schedule 2.” – Medical advisor to Harmony", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:35.594+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "30e8439b-4df9-43ad-a451-9e721e5bc467", "parentComponentId": null }, { "bbox": { "h": 0.32, "w": 0.86, "x": 0.07, "y": 0.61 }, "kind": "paragraph", "text": "Incremental benefit at best; docs have to prescribe scheduled substances anyway\nQ: “How much of an advantage is that Wakix is not controlled – aren’t all the people prescribing this already registered with the DEA?”\nA: “It depends. Your point is well taken. For instance, from my perspective, most patients I treat with narcolepsy are going to be a 2 or 3-agent regimen, and those are going to involve things that are at least Schedule 4, sometimes Schedule 2, and Xyrem in between Schedule 3...there are other clinics that are very, very happy to just keep writing stimulants for everybody, and they don’t want to deal with this, but at the same time, those are the people who are the most resistant, I think, oxybate, and the fact that this is a simple regimen, that also is a factor. I think the major challenge for any of the newer agents, there’s a lot of inertia for some of these clinics where stimulants get approved, they’re cheap, you write it, the patient goes and picks it up at the pharmacy, that’s it. There’s no prior auth, there’s no appeal, there’s no annoying paperwork. And that happens with oxybate and with pitolisant. So, some people, whatever they say, they just don’t want to deal with it. But that was a tangential answer, I’m sorry. But I do think it has some benefit to having it not being controlled. I think that the folks at Harmony market that stronger than probably it carries with clinicians, but it’s not nothing.”\nQ: “No, I get it. It’s an incremental benefit.”\nA: “Yeah.” – Medical advisor to Harmony", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:35.594+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "a474813a-f1a7-441d-aafd-b309eef244b2", "parentComponentId": null }, { "bbox": { "h": 0.25, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "A physician who is a medical advisor to Harmony concurred, saying “it’s not that big a deal” as scheduled drugs can still be prescribed for 6 months at a time, particularly key competitors like Xywav and Xyrem, and that the additional work is “not much.” He stated he already has to write scheduled drugs for all the same patients anyway: “most patients I treat with narcolepsy are going to be a 2 or 3-agent regimen, and those are going to involve things that are at least Schedule 4.” He added that “the folks at Harmony market that stronger than probably it carries with clinicians” and indicated it’s at best an incremental benefit.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:35.594+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "dc0b5793-46c0-4411-921a-6c70b1c4a0c2", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "“it’s not that big a deal” — Medical advisor to Harmony; “most patients I treat with narcolepsy are going to be a 2 or 3-agent regimen, and those are going to involve things that are at least Schedule 4.” — Medical advisor to Harmony; “the folks at Harmony market that stronger than probably it carries with clinicians” — Medical advisor to Harmony", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:52+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d1-73a9-abbb-9459012db23b", "parentComponentId": null }, { "bbox": { "h": 0.03, "w": 0.3, "x": 0.07, "y": 0.95 }, "kind": "source-note", "text": "Source: Scorpion Capital consultation calls with experts", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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We quote two different prescribers below.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:29.844+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "396fca15-f9c7-48f4-8c44-145f28182048", "parentComponentId": null }, { "bbox": { "h": 0.03, "w": 0.86, "x": 0.07, "y": 0.68 }, "kind": "quote", "text": "Harmony overplays the benefit: “they play the schedule thing really hard”; Harmony is harder to prescribe", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": null, "subkind": { "name": "Testimonial", "slug": "testimonial", "status": "active", "canonId": "019de52c-fc21-71b6-9ac3-8266a64945e8", "version": 1, "description": null }, "framework": null }, "subkind": "testimonial", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:29.844+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "87276f63-5179-4a48-9812-708f17044884", "parentComponentId": null }, { "bbox": { "h": 0.03, "w": 0.86, "x": 0.07, "y": 0.44 }, "kind": "quote", "text": "“Meaningless” benefit from non-controlled substance given Harmony’s centralized pharmacy “made it so difficult”", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": null, "subkind": { "name": "Testimonial", "slug": "testimonial", "status": "active", "canonId": "019de52c-fc21-71b6-9ac3-8266a64945e8", "version": 1, "description": null }, "framework": null }, "subkind": "testimonial", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:29.844+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "8e67ee45-ddd1-4ea3-a75e-368abbe2cdae", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "\"they made it so difficult...because of the centralized pharmacy...any benefit...is basically in the wash...practically meaningless.\" — Physician and professor of neurology at a large academic center; \"they play the schedule thing really high\"...\"what you have to jump through\"...\"it shouldn't be this hard.\" — Physician in private and academic practice in PA", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:52+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d1-73a9-abbb-bfd2c57e7831", "parentComponentId": null }, { "bbox": { "h": 0.02, "w": 0.3, "x": 0.07, "y": 0.95 }, "kind": "source-note", "text": "Source: Scorpion Capital consultation calls with experts", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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You always have to, like with Wakix.", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": { "name": "Visual emphasis", "slug": "visual-emphasis", "status": "active", "bestFor": null, "canonId": "019dd9e1-474b-736b-a8eb-a794dd88241c", "version": 1, "bodyDocId": null, "description": "Drawing the eye to one element above the rest of the slide.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:50:00+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d1-73a9-abbe-e87d2273eb7d", "parentComponentId": null }, { "bbox": { "h": 0.65, "w": 0.86, "x": 0.07, "y": 0.26 }, "kind": "paragraph", "text": "Doctors “hate” having to deal with Wakix’s pharmacy... Docs “quite disappointed” at the “burden of prescribing” Wakix... Harmony “drove that home” re being non-scheduled, but Wakix is “so complicated” given centralized pharmacy", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:30.748+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "69853585-a803-4cc0-942d-6cd42d471314", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "“Oh, I just hate any—you know, I just like to go to my little prescription box, type it in, and submit. I hate having to fill out a separate form and all this other crap. You always have to, like with Wakix.” — Neurologist who is a sleep specialist and professor at leading institution; “I think the excitement for this is on the wane... quite disappointed by how the burden of prescribing has really interfered with our ability to get people on it.” — Physician and professor of neurology at a large academic center; “They drove that home, that it’s non-scheduled, and I think it was more of a mindset that it was a safe medication so therefore it didn’t have to be scheduled. But they just make it so complicated when they had their own pharmacy delivering it. 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"extraction": { "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "at": "2026-05-02 20:18:32.086+00", "seconds": 3.601, "promptVersion": "v2-canon-conditioned" } }, "links": { "slide": "/slides/019dd923-622c-750b-8b9a-21918ac10c17/297", "deck": "/decks/019dd923-622c-750b-8b9a-21918ac10c17", "deckAnchor": "/decks/019dd923-622c-750b-8b9a-21918ac10c17#slide-297", "deckJson": "/decks/019dd923-622c-750b-8b9a-21918ac10c17.json" }, "components": [ { "bbox": null, "kind": "callout", "text": "Harmony shows no citations, papers, or studies in support of the claim that pitolisant “increases histamine levels in the brain.”", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": { "name": "Visual emphasis", "slug": "visual-emphasis", "status": "active", "bestFor": null, "canonId": "019dd9e1-474b-736b-a8eb-a794dd88241c", "version": 1, "bodyDocId": null, "description": "Drawing the eye to one element above the rest of the slide.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:53+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d1-73a9-abbc-10ae8879f8bb", "parentComponentId": null }, { "bbox": { "h": 0.12, "w": 0.75, "x": 0.07, "y": 0.77 }, "kind": "paragraph", "text": "EMA review\nIn vivo studies showed that pitolisant enhanced the activity of histaminergic neurons as shown by the increase in brain levels of t-MeHA with oral ED50 values reaching 1.6-2.6 mg/kg in mice and 3 mg/kg in rats.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:32.086+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "42a64a80-0f47-4fe5-b616-fd088dacac9d", "parentComponentId": null }, { "bbox": { "h": 0.45, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "Harmony shows no citations, papers, or studies in support of the claim that pitolisant “increases histamine levels in the brain.” Nor could we locate any discussion of the claim in any of the FDA review documents...", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose 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Background\nPitolisant is a histamine 3 (H3) receptor antagonist and inverse agonist. 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First, both papers measure a histamine metabolite (T-meha) and not histamine, a questionable method with no evidence of its validity. One of these papers states that “t-meha levels [are] an index of histaminergic activity,” citing a 1991 paper by Schwartz, which we read and merely passes the buck by citing rodent studies from the 1970’s and early 1980’s. 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No association was found between CSF HA, t-MHA, or HA + t-MHA, sleepiness, treatment intake, and frequency of cataplexy.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:35.169+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "1fe40ae0-be63-4794-9880-92bbbe5bafa7", "parentComponentId": null }, { "bbox": { "h": 0.45, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "Even if there was evidence that pitolisant increases histamine levels in the brain, it wouldn't matter as Bioprojet once published a study that unequivocally discredits the purported mechanism of action.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:35.169+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "a08e827d-a32d-4891-a3fc-22f009c6f450", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "Conclusion: CSF histamine and tele-methylhistamine did not significantly differ between patients with narcolepsy-cataplexy and other etiologies of non-hypocretin-1 deficient central hypersomnias; these measurements, therefore, are not useful in assessing the etiology or severity of centrally mediated hypersomnia. — Yves Dauvilliers et al., 2012", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:54+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d1-73a9-abbd-08e42f03437b", "parentComponentId": null }, { "bbox": { "h": 0.03, "w": 0.45, "x": 0.07, "y": 0.94 }, "kind": "source-note", "text": "Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3443762/pdf/aasm.35.10.1359.pdf", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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Being without significant difference between groups. we believe. from a clinical point of view. that the measurement of CSF HA and t-MHA are not informative tools to differentiate etiologies of central hypersomnia or to assess the severity of centrally mediated hypersomnia. However,", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:32.392+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "33fc02cf-b454-4214-b5ea-24f210bb7810", "parentComponentId": null }, { "bbox": { "h": 0.35, "w": 0.43, "x": 0.07, "y": 0.51 }, "kind": "paragraph", "text": "Altogether, even if discrepancies exist between studies,5-8 CSF measurements of both HA and t-MHA appear non-informative biomarkers to diagnose and differentiate between etiologies of central hypersomnia with or without hypocretin deficiency. Our results may contrast with the positive clinical findings of the inverse agonist of the H3 receptor that enhance wakefulness in normal animals and decreases EDS in orexin-/- mice and human narcoleptic.25 However, our present results were in agreement to those reported between orexin-/- mice and WT mice showing normal cortical activity of HA neurons (assessed by measuring the cortical level of t-MHA) during the dark (active) period at baseline.25", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:32.392+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "3df2fc2c-c2e1-4c53-8d1e-18f3fbc46ada", "parentComponentId": null }, { "bbox": { "h": 0.35, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "The paper is striking in its honesty, which we attribute to Bioprojet already having terminated pitolisant by 2012, given its omission in Bioprojet papers around that time which mention other “lead compounds” for its H3 receptor program. The paper even reframes the original 2007 rodent paper, which is the primary evidence that pitolisant increases histamine levels in the brain, stating that it showed that there was no difference in histamine levels between control mice and orexin mice bred to have narcolepsy. We paste the concluding section of the study below: that histamine is a “non-informative biomarker...to diagnose...etiologies of central hypersomnia” and that “from a clinical point of view” histamine levels are “not informative tools to differentiate etiologies of central hypersomnia or to assess the severity of centrally mediated hypersomnia.”", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:32.392+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "a7b058ec-8a77-4342-a2e7-a08bd8e87812", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "“non-informative biomarker...to diagnose...etiologies of central hypersomnia” and that “from a clinical point of view” histamine levels are “not informative tools to differentiate etiologies of central hypersomnia or to assess the severity of centrally mediated hypersomnia.” — Bioprojet paper", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-23 01:18:10+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-70f3-714d-84c7-402e4c5118ee", "parentComponentId": null }, { "bbox": { "h": 0.02, "w": 0.4, "x": 0.07, "y": 0.95 }, "kind": "source-note", "text": "Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3443762/pdf/aasm.35.10.1359.pdf", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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The author, a neurology professor and leading scientist in sleep research, called it “a back to the drawing board moment” that undermined the “very seductive tale in which the protagonist is brain histamine.” He slammed the previous pitolisant studies and detailed “additional methodological concerns” with the now-discredited histamine hypothesis, concluding that the finding “is not at all surprising” and that “this should temper concluding that…histamine…is the principal arbiter of sleepiness in primary hypersomnias.”", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:33.023+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "434a3d4c-945d-43b1-aa66-f4c57440f15a", "parentComponentId": null }, { "bbox": { "h": 0.3, "w": 0.86, "x": 0.07, "y": 0.61 }, "kind": "paragraph", "text": "the analytical methodology employed. An additional point of agreement between these studies was that CSF histamine and t-MH failed to correlate with any clinical metric of sleepiness. This should further temper concluding that reduction in CSF histamine bioactivity is the principal arbiter of sleepiness in primary hypersomnias. It is also a reminder of the diversity of alternate factors that can influence the complex trait of sleepiness.25,26 Time between CSF sampling and sleep/sleepiness assessments, the inadequacy of metrics to capture sleepiness, the reliance on verbal reports and psychometrics of sleepiness, and individual differences in compensatory wake promoting substances or endogenous somnogens are a few of several factors that could account for the inability to correlate CSF histamine markers with sleepiness metrics. It is safe to say that the findings of Dauvilliers et al.13 point us back to the drawing board in search of a biomarker and mechanistic details with relevance to the diagnosis and treatment of the primary hypersomnias.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:33.023+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "6b1d4ce4-349e-47af-a7e8-6ce50b0610d8", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "a back to the drawing board moment — Neurology Professor/Author of SLEEP editorial. very seductive tale in which the protagonist is brain histamine. — Neurology Professor/Author of SLEEP editorial. additional methodological concerns — Neurology Professor/Author of SLEEP editorial. is not at all surprising — Neurology Professor/Author of SLEEP editorial. this should temper concluding that...histamine...is the principal arbiter of sleepiness in primary hypersomnias. — Neurology Professor/Author of SLEEP editorial.", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:54+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d1-73a9-abbc-87d2521dc0a4", "parentComponentId": null }, { "bbox": { "h": 0.02, "w": 0.4, "x": 0.07, "y": 0.95 }, "kind": "source-note", "text": "Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3443754/pdf/aasm.35.10.1315.pdf", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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Histamine: neural circuits and new medications; Histamine Is Not a Reliable Biomarker for Narcolepsy and Other Central Hypersomnias", "attrs": null, "canon": { "kind": { "name": "List", "slug": "list", "status": "active", "canonId": "019de52c-f94b-779b-a53b-fd4904a5f4d2", "version": 1, "description": "Bullet or numbered list." }, "tool": null, "subkind": { "name": "Bullet list", "slug": "bullet", "status": "active", "canonId": "019de52c-fc98-7169-a083-5cab805076ca", "version": 1, "description": null }, "framework": null }, "subkind": "bullet", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:37.885+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "ad3d5f08-97a6-4380-b7a7-a812903616f6", "parentComponentId": null }, { "bbox": { "h": 0.15, "w": 0.45, "x": 0.48, "y": 0.4 }, "kind": "list", "text": "...citing various studies showing no link to sleepiness; Histamine and tele-methylhistamine quantification in cerebrospinal fluid from narcoleptic subjects by liquid chromatography tandem mass spectrometry with precolumn derivatization", "attrs": null, "canon": { "kind": { "name": "List", "slug": "list", "status": "active", "canonId": "019de52c-f94b-779b-a53b-fd4904a5f4d2", "version": 1, "description": "Bullet or numbered list." }, "tool": null, "subkind": { "name": "Bullet list", "slug": "bullet", "status": "active", "canonId": "019de52c-fc98-7169-a083-5cab805076ca", "version": 1, "description": null }, "framework": null }, "subkind": "bullet", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:37.885+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "f69bfcb4-ce5d-4358-8270-7bee574eedda", "parentComponentId": null }, { "bbox": { "h": 0.25, "w": 0.43, "x": 0.07, "y": 0.58 }, "kind": "paragraph", "text": "furthermore, histamine levels did not correlate with subjective (Epworth Sleepiness Scale) and objective (Multiple Sleep Latency Test) measures of sleepiness or CSF orexin-A levels [85]. These results were in agreement with the normal cortical levels of tele-methyl histamine in orexin-/-mice compared with wild-type mice [20]. In a small number of patients with narcolepsy, CSF was collected again several months after the first sample; yet, histamine and tmHA levels showed no consistent change [86]. Altogether these data suggest that despite the increased number of HDC cells, extracellular histamine levels are likely normal in patients with narcolepsy.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:37.885+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "165e7af8-4cca-4cfb-90eb-2770666075ad", "parentComponentId": null }, { "bbox": { "h": 0.15, "w": 0.45, "x": 0.48, "y": 0.58 }, "kind": "paragraph", "text": "selective requirement to quantify these amines in human CSF. No significant difference was found in the mean±standard error levels of these amines between a group of narcoleptic patients (histamine=392±64pM, tele-methylhistamine=2431±461pM, n=7) and of neurological control subjects (histamine=402±72pM, tele-methylhistamine=2209±463pM, n=32).", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:37.885+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "269f98c0-ed0f-40ed-9934-16b0b2adfc37", "parentComponentId": null }, { "bbox": { "h": 0.15, "w": 0.86, "x": 0.07, "y": 0.22 }, "kind": "paragraph", "text": "CEO Jeff Dayno has previously highlighted Thomas Scammell on a HRMY earnings call, a neurology professor and sleep expert at Harvard Medical School. Scammell wrote a paper in 2019 which summarized supportive studies that undermine the histamine hypothesis, beyond the 2012 Dauvilliers/Schwartz paper. For example, he cites another paper – on which Dauvilliers/Schwartz are ironically co-authors – that found no difference in histamine or T-meha levels between narcolepsy vs. control patients.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:37.885+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "ec13a222-e18e-4226-a122-217486a381bc", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "Histamine Is Not a Reliable Biomarker for Narcolepsy and Other Central Hypersomnias — Thomas Scammell (2019 paper).", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:54+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d1-73a9-abbc-9df652e52697", "parentComponentId": null }, { "bbox": { "h": 0.03, "w": 0.75, "x": 0.07, "y": 0.95 }, "kind": "source-note", "text": "Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6335869/pdf/zsy183.pdf; https://www.sciencedirect.com/science/article/abs/pii/S0003269710006433?via%3Dihub", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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There are numerous problems with the determination of F% by mass balance...", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": null, "subkind": { "name": "Pull quote", "slug": "pull-quote", "status": "active", "canonId": "019de52c-fbf9-76fe-97e1-a0b7540445c9", "version": 1, "description": null }, "framework": null }, "subkind": "pull-quote", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:32.338+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "189ffca2-e06d-4a02-817e-3f722a9b347a", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "According to the EMA, the absolute bioavailability of Pitolisant “has not been determined”. (EMA 2015, p 34). 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20:18:35.9+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "9c5dde64-4d9d-4d0e-b424-854f8c027545", "parentComponentId": null }, { "bbox": null, "kind": "metric", "text": "drug concentration: ~20X", "attrs": null, "canon": { "kind": { "name": "Metric", "slug": "metric", "status": "active", "canonId": "019de52c-f923-73bf-8081-d0b1a8c5264d", "version": 1, "description": "Big-number or KPI value." }, "tool": { "name": "Quantification", "slug": "quantification", "status": "active", "bestFor": null, "canonId": "019dd9e1-47ab-72ce-a079-aab1f5299e88", "version": 1, "bodyDocId": null, "description": "Translating a claim into numbers, charts, or tables.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": "primary", "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:54+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, 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The blood/brain barrier is a major obstacle in the development of CNS drug delivery and a class problem with H3 receptor antagonists/inverse agonists – one of many impediments conveyed to us by scientists involved in failed H3 receptor drug programs at several large pharma companies. The only CNS uptake data we can locate for pitolisant is from rodent studies in the 2000’s – no human data appears to be available. Our pharmacology consultant reviewed the data and found it suspect and troubling. First, the study failed to use a standard methodology for measuring CNS uptake in rodents called quantitative whole-body autoradiography (QWBA). The study instead homogenized the brains after sacrificing the mice, presumably centrifuging to measure ng/g concentrations. 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Serum and Brain levels of Pitolisant and major metabolites in Sprague-Dawley Rats After Single Oral Dose of Pitolisant at 400 mg/kg", "attrs": null, "canon": { "kind": { "name": "Table", "slug": "table", "status": "active", "canonId": "019de52c-f9c8-7148-8119-eaac9594cd28", "version": 1, "description": "Tabular data layout." }, "tool": null, "subkind": { "name": "Data table", "slug": "data", "status": "active", "canonId": "019de52d-02d5-75b8-8abf-88e92bf63569", "version": 1, "description": null }, "framework": null }, "subkind": "data", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:34.117+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "74234c6a-fc30-46b1-ab52-20ca06cb59d9", "parentComponentId": null }, { "bbox": { "h": 0.4, "w": 0.45, "x": 0.07, "y": 0.45 }, "kind": "table", "text": "Table 26. Pitolisant Levels in Serum and Brain Tissue 15 Minutes Post-Dose Versus After Premature Death Following i.v. 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They consistently described the company’s sales and business model as being dependent on a small number of high-volume prescribers – “whales” who are typically paid promotional speakers, which the ex-employees described as a quid pro quo and inducement for doctors willing to write large numbers of Wakix prescriptions. Speaker’s programs which constitute kickbacks or rewards are flagrantly illegal, resulting in high-profile indictments of executives of companies – Insys, for example, being a recent poster-child where the CEO, physicians, and others were sentenced to prison. Fraudulent speakers programs are the target of heightened scrutiny, as evidenced by a 2020 “Special Fraud Alert: Speaker Programs” issued by the HHS Office of Inspector General. 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Yes, there were a lot of representatives that their performance had fallen way off. My question is, the very successful territories had speakers in them and, you know, when you pay somebody to do talks for you, you tend to get—it's harped upon, it cannot be quid pro quo but, let's be honest, to a degree, you pay somebody a stipend to do a talk for you, and you continue to do that, they tend to look to use your drug. I'm not saying that they're going to use it in inappropriate places, but they look to use your drug more frequently. 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[Quote text] ... - Ex-Harmony territory manager for a large region in the southeast across two states", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": null, "subkind": { "name": "Testimonial", "slug": "testimonial", "status": "active", "canonId": "019de52c-fc21-71b6-9ac3-8266a64945e8", "version": 1, "description": null }, "framework": null }, "subkind": "testimonial", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:34.695+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "d1b4bd14-10a9-410d-86b9-c312b69abfb5", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "“There is another board-certified sleep specialist. This guy is a complete—forgive my language—whore when it comes to the pharma industry... Their number-one prescriber, number one in the United States, is a friend of mine... We hang out socially and so forth. His name is [redacted]. I would call it to him and say it to his face. 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So, he was probably writing maybe 5 or 6 of those 20 a quarter.", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": { "name": "Visual emphasis", "slug": "visual-emphasis", "status": "active", "bestFor": null, "canonId": "019dd9e1-474b-736b-a8eb-a794dd88241c", "version": 1, "bodyDocId": null, "description": "Drawing the eye to one element above the rest of the slide.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:57+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d1-73a9-abbd-aa97e1002349", "parentComponentId": null }, { "bbox": { "h": 0.55, "w": 0.86, "x": 0.07, "y": 0.29 }, "kind": "paragraph", "text": "Q: “How many doctors did you call on in your territory?”\nA: “I think my list was about 150 or 175. would say maybe I had 90 I saw on a rotating basis.”\nQ: “And how many did you get to write the prescription at least once? And then what percentage of those ended up being consistent writers or whales?”\nA: “I had very few whales in my territory, which made it even more difficult for me, even though I did well.”\nQ: “So, who was your biggest prescriber? How many scripts was that?”\nA: “My biggest prescriber was actually a doctor who toggled between [hospital name redacted] and [city redacted].”\nA: “I would say by the time I left, so my goal was usually around 20 per quarter, which is astronomical when you’re talking about rare disease, that’s a lot. So, he was probably writing maybe 5 or 6 of those 20 a quarter.”\nQ: “And then, how about your next biggest? So, he’s writing about 20 a year. Who was your next biggest one?”\nA: “My next biggest one was one of the doctors at [hospital redacted]. 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quid pro quo; prescriptions correlated to being put on or off a speakers program", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": null, "subkind": { "name": "Primary callout", "slug": "primary", "status": "active", "canonId": "019de52c-fbd1-70eb-a9ce-8997f8674c1d", "version": 1, "description": null }, "framework": null }, "subkind": "primary", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:35.491+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "9437ca9e-1b90-486b-aa11-998af2f08370", "parentComponentId": null }, { "bbox": { "h": 0.25, "w": 0.86, "x": 0.07, "y": 0.15 }, "kind": "paragraph", "text": "“there was always an overhanging threat of being put on a disciplinary plan if you didn’t get a certain amount of speaker programs within your territory.” He stated there were “certain quotas” that were “pushed down from upper management” and that doctors “were more willing to write if they were promised” a “speakership or sponsorship program” – “I don’t know if it was a quid pro quo but it felt like…where a doctor suddenly popped up as a primary speaker and he or she would write of a lot of prescriptions.” Giving away the rig, he added that “then they were taken off the speaker list and all of a sudden the prescriptions dropped…that always raises an eyebrow – is there a quid pro quo….”", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:35.491+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "983764b0-2053-4597-8767-3b7f7a1a642a", "parentComponentId": null }, { "bbox": { "h": 0.42, "w": 0.86, "x": 0.07, "y": 0.49 }, "kind": "paragraph", "text": "A: “Yeah, there was always an overhanging threat of being put on a disciplinary plan if you didn’t get a certain amount of speaker programs within your territory. Those were difficult to get in some areas. The doctors also were more willing to write if they were promised and actually a speakership or sponsorship program. In some areas, I don’t know if it was a quid pro quo, but it felt like that in some areas where a doctor suddenly popped up as a primary speaker, and he or she would write a lot of prescriptions. And then they were taken off the speaker list, and all of a sudden, the prescriptions dropped down. So, there was that that always raises an eyebrow—is there a quid pro quo with certain doctors that makes them write prescriptions because they’re being paid for a program that they—”\nQ: “You said there’s a threat of disciplinary action if a rep didn’t get enough doctors in the speaker program? What was that about?”\nA: “Basically, there were certain quotas that had to be attained, and this was down from upper management; it was pushed down. They expected a certain amount of speaker programs in each territory per quarter. 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In other words, you’ve got to get enough doctors to write enough scripts so that they actually get bumped into the speaker’s program. Any color around that or pressure?”\nA: “There was some unspoken pressure that if a doctor was a speaker and they weren’t filling prescriptions, they would be taken off the program. That was not communicated between the doctors and the company, but, in my case, I did have a doctor that was underwhelming as far as writing prescriptions; very excited to jump on board and do a speaker’s program but just would not write prescriptions for his patients. So, he was actually asked to be taken off the list. It was never because you’re not writing prescriptions. We never said that; we never brought that to their attention, but it was always felt that that was the reason why the doctor was taken off the speaker’s program.”\nQ: “Is that pretty common across territories? 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He further added that the doctor rarely even did speaking engagement – “he turned down almost every speaking engagement that I ever offered him.” When we asked if he was being paid as a speaker but not actually speaking, the ex-employee replied “absolutely correct,” and even explained that the doctor “was horrible...he was absolutely horrible...a complete disaster” when he had him do a talk.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:40.017+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "05400b55-3279-40d2-a5f1-3852a1c9c8e2", "parentComponentId": null }, { "bbox": { "h": 0.55, "w": 0.86, "x": 0.07, "y": 0.35 }, "kind": "quote", "text": "“Absolutely 100%” that the speaker’s program was basically an inducement to write prescriptions\nQ: “Were there doctors that the company or people knew, you know, these whales, where it’s all about the speaker’s program, writing scripts left and right?”\nA: “Yes. The guy that I referenced that I had, absolutely, 100%.”\nQ: “[speaker name redacted]?\nA: “100%. Exactly, yeah. I feel bad. I kind of like [speaker name redacted].”\nQ: “What leads you to have that opinion?”\nA: “Because he speaks for every—he’ll blow out any new drug that comes to market because he wants to be considered a speaker. And here’s the really crazy part to that, he turned down almost every speaking engagement that I ever offered him. The only ones he would do would be miles from his home. He didn’t want to travel. He did well. I think he’s got 6-8 different offices. He’s in [redacted], he’s in [redacted], and he’s in [redacted]. He’s making a really nice living. So, I think he literally just wanted to be a speaker, so it was like—”\nQ: “So, [redacted] was being paid as a speaker, but you’re saying he wasn’t really speaking that much?”\nA: “Absolutely correct. And he was horrible. He was absolutely horrible. 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"text": "INDICATIONS AND USAGE\nWAKIX is a histamine-3 (H3) receptor antagonist/inverse agonist indicated for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy (1)", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:36.026+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "a45760ae-d4ff-4e87-9a60-e7101110716a", "parentComponentId": null }, { "bbox": { "h": 0.35, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "Ex-territory managers and those in a field reimbursement role described a vast off-label prescribing scheme as key to Harmony’s sales. The Wakix label is clear and specific, stating as follows for “INDICATIONS AND USAGE”: “WAKIX is a histamine-3 (H3) receptor antagonist/inverse agonist indicated for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy.” Patients must have narcolepsy, and if so, Wakix may be prescribed for 1) EDS and/or 2) cataplexy. However, narcolepsy is extremely rare, and narcolepsy with cataplexy is a small fraction of that number. A recent epidemiological study estimated the incidence of narcolepsy at ~40 per 100,000 or ~130K in the US (0.04%); another pegged narcolepsy with cataplexy at 4.87 per 100,000 (.005%), or 16K – in other words, only 12% of narcoleptics have cataplexy.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:36.026+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "df98be6f-66a2-4083-ba2b-4abe6fb55576", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "WAKIX is a histamine-3 (H3) receptor antagonist/inverse agonist indicated for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy (1) — Wakix label", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:58+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d1-73a9-abbe-71ef1887c22a", "parentComponentId": null }, { "bbox": { "h": 0.03, "w": 0.4, "x": 0.07, "y": 0.91 }, "kind": "source-note", "text": "Source: https://jcsm.aasm.org/doi/10.5664/jcsm.8482; https://pubmed.ncbi.nlm.nih.gov/31004158/", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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company told reps to exploit “vagueness of narcolepsy” to push physician to diagnose it even when it’s not there; “gray areas”", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": null, "subkind": { "name": "Primary callout", "slug": "primary", "status": "active", "canonId": "019de52c-fbd1-70eb-a9ce-8997f8674c1d", "version": 1, "description": null }, "framework": null }, "subkind": "primary", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:37.481+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "458ec7f0-97a8-419e-a52e-8ac534b9ac3c", "parentComponentId": null }, { "bbox": null, "kind": "callout", "text": "It appears that reps would latch onto a patient with narcolepsy and then try to get the physician or their office to expand the diagnosis to cataplexy – even if the patient didn't have it – to “comply” with the label.", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": { "name": "Visual emphasis", "slug": "visual-emphasis", "status": "active", "bestFor": null, "canonId": "019dd9e1-474b-736b-a8eb-a794dd88241c", "version": 1, "bodyDocId": null, "description": "Drawing the eye to one element above the rest of the slide.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:57+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d1-73a9-abbe-03dabf744b06", "parentComponentId": null }, { "bbox": { "h": 0.35, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "When we asked another ex-territory manager if there were verbal, non-written instructions to the sales team to encourage off-label prescribing, he replied that it was to use “the vagueness of narcolepsy...so look for it...gray areas, like once you get that low-hanging fruit...start expanding...you gotta expand the diagnosis of narcolepsy.” We emphasize that Wakix is not indicated as a treatment for narcolepsy: it is only approved for two symptoms - EDS or cataplexy - in patients who have narcolepsy. 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I’m just curious.”\nA: “The vagueness of narcolepsy, saying for CPAP, it’s 30% of patients that fail CPAP are narcoleptic. I have no idea where they got that number from. Thirty percent of CPAP failures, everybody failed CPAP. CPAP sucks. So, somehow, they came up with the number 30%. Tell your physicians that 30% of all CPAP failures are narcoleptic patients, so look for it. Gray areas like, once you get that low-hanging fruit, start expanding. You gotta expand the diagnosis of narcolepsy. But the insurance companies are smart to that. You must have a certain amount of non-REM or failed REMS.”\nQ: “So, they were basically instructions from the company to get the doctor to kind of suggest that the patient had narcolepsy when they may not have it—just to be very liberal with the definition of it?”\nA: “Yes. If you think about it, is it unethical? Yes, it is. However, we weren’t treating narcolepsy; we were treating excessive daytime sleepiness. 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We presume this has the obvious and intended effect: reps proliferate bogus referral forms, particularly the top performers, according to ex-employees, with one stating a current territory manager \"just [told] me yesterday that...he still does it\": \"if you had a buddy, a doctor and say, hey listen, submit the form and then just ghost them...just submit the form and don't even worry about...the insurance information...I'll get paid for it...some representatives did that frequently.\"", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:39.574+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "bbcf3fbb-124c-4352-84f7-b8876a6bb979", "parentComponentId": null }, { "bbox": { "h": 0.42, "w": 0.86, "x": 0.07, "y": 0.51 }, "kind": "quote", "text": "A: \"There were also some reps that, since we were paid only, pretty much only on driving those referrals in, if you had a buddy, a doctor and say, hey listen, submit the form and then just ghost them. Don't even worry about it. Just submit the form and don't even worry about filling out the insurance information. I'll get paid for it and then tell them that the patient changed their mind, or you changed their mind, or you went in another direction, or whatever. I guess that there are some representatives that did that frequently. Really, that was my motivation to see those refill links because I wanted to know how this one representative in Columbus, Ohio—my goal was 20, and she was putting up 50, 60 a quarter, every quarter. I'm like, I wonder how many of those patients are really on drug, and how many were just \"fill out the form and don't worry about it.\" I know it goes on. I had a representative just yesterday tell me that, yeah, he still does it.\"\nQ: \"Still does what? That he's just submitting scripts he knows aren't going to get approved?\"\nA: \"Yeah. You have somebody who's a good friend of yours—because you're really asking a lot to do that. You're asking a doctor to pretty much go against a lot of what he was trained upon. That's not appropriate. So, he better be even more than a guy you have beers with. He better be your buddy. And you can ask him and say, hey, just submit it, and I get credit and then forget about it. I know it goes on, but I don't know what degree. I suspect that some of the very successful reps quarter over quarter over quarter with no downturn because it's cyclic, it is, it's a rare disease, and it becomes cyclical, you're not going to hit your number every single quarter. You're certainly not going to blow your number out every quarter, and there are a handful of representatives at Harmony that continually do quarter after quarter. I suspect that was part of their plan, part of the process, but I don't know that for a fact.\" – Ex-Harmony territory manager for an eastern state", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": null, "subkind": { "name": "Testimonial", "slug": "testimonial", "status": "active", "canonId": "019de52c-fc21-71b6-9ac3-8266a64945e8", "version": 1, "description": null }, "framework": null }, "subkind": "testimonial", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:39.574+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "a01700f4-65b2-4bce-a5d2-ef92d18cc45d", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "\"There were also some reps that, since we were paid only, pretty much only on driving those referrals in, if you had a buddy, a doctor and say, hey listen, submit the form and then just ghost them. Don't even worry about it. Just submit the form and don't even worry about filling out the insurance information. I'll get paid for it and then tell them that the patient changed their mind, or you changed their mind, or you went in another direction, or whatever. 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0.47 }, "kind": "callout", "text": "Surprise and skepticism in salesforce of referral forms being jammed into the hub; huge anomalies across the company with prescriptions far higher than plausible number of narcolepsy patients; weird swings", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": null, "subkind": { "name": "Primary callout", "slug": "primary", "status": "active", "canonId": "019de52c-fbd1-70eb-a9ce-8997f8674c1d", "version": 1, "description": null }, "framework": null }, "subkind": "primary", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:37.1+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "7930bdcf-5763-4873-b888-ee551f26e3df", "parentComponentId": null }, { "bbox": null, "kind": "callout", 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"4e258ea4-7809-400c-b67a-6c2fbd1f02c8", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "people on my team...would just go and find a doctor and hey man, just try to send as many through for me as you can...if they became close with the doc, then they could...send them through. — Ex-Harmony territory manager for a large Midwest state", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:49:57+00", 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They’ll fax them in. They’ll sit there with the MA and find patients that they can, let’s go through your patients and find out what patients are on modafinil and are they a candidate for Wakix. They’ve been on modafinil for five years. They’re still kind of complaining of being sleepy. Let’s try those. Let’s get a list, call the patients in, I’ll help you fill out a form, send them in—stuff like that.”\nQ: “Is that not allowed?”\nA: “No, honestly, in order to make goal in a lot of these companies and the way that they raise your commission, you’re really forced to do that. And you can stay and do it, or you cannot, and you can leave. If you’re not happy there and you’re not going to make goal, then you’ve got a couple of choices you can make. Did the managers know that reps are doing this? If they do, they’re blind to it, they don’t want to know. Don’t tell me. Just don’t tell me. Does upper management now? 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"attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": null, "subkind": { "name": "Primary callout", "slug": "primary", "status": "active", "canonId": "019de52c-fbd1-70eb-a9ce-8997f8674c1d", "version": 1, "description": null }, "framework": null }, "subkind": "primary", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:38.74+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "97f2c9e2-7ca9-4802-ab4d-2548745de259", "parentComponentId": null }, { "bbox": { "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "A high volume prescriber and speaker for Harmony confirmed the color from reps regarding alleged off-label prescribing, stating that “the speakers that you’re talking about...they’re doing to give it to excessive daytime sleepiness patients because you can find a lot of those, and it’s an unclear diagnosis, and you can put them on it.” A former territory manager provided an example of the unusual patient flows that would result, speaking sarcastically of a colleague: “I don’t know why there are 30 or 40 narcolepsy patients...in Flint, Michigan...no idea why...but she’s doing it, and she’s making a crap ton of money doing it.”", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:38.74+00", "model": 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I don’t know why there are 30 or 40 narcolepsy patients or so many narcolepsy patients in Flint, Michigan, no idea why. But she’s doing it, and she’s making a crap ton of money doing it.” – Ex-Harmony territory manager for several states in the Northeast", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": null, "subkind": { "name": "Testimonial", "slug": "testimonial", "status": "active", "canonId": "019de52c-fc21-71b6-9ac3-8266a64945e8", "version": 1, "description": null }, "framework": null }, "subkind": "testimonial", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:38.74+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "509c22f6-e568-4b44-9f95-e242466c1cee", "parentComponentId": null }, { "bbox": { "x": 0.07, "y": 0.4 }, "kind": "quote", "text": "“I think the speakers that you’re talking about, they’re going to give to excessive daytime sleepiness patients because you can find a lot of those, and it’s an unclear diagnosis, and you can put them on it.”-Neurologist in New York with 70-80 narcolepsy patients", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": null, "subkind": { "name": "Testimonial", "slug": "testimonial", "status": "active", "canonId": "019de52c-fc21-71b6-9ac3-8266a64945e8", "version": 1, "description": null }, "framework": null }, "subkind": "testimonial", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:38.74+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "e3186316-facb-48d9-9df5-2fd614822ea7", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "“the speakers that you’re talking about...they’re doing to give it to excessive daytime sleepiness patients because you can find a lot of those, and it’s an unclear diagnosis, and you can put them on it.” — Neurologist in New York with 70-80 narcolepsy patients. “I don’t know why there are 30 or 40 narcolepsy patients...in Flint, Michigan...no idea why...but she’s doing it, and she’s making a crap ton of money doing it.” — Ex-Harmony territory manager for several states in the Northeast", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:50:01+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d1-73a9-abc0-4c1513b1f42e", "parentComponentId": null }, { "bbox": { "x": 0.07, "y": 0.95 }, "kind": "source-note", "text": "Source: Scorpion Capital consultation calls with experts", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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In other words, reps are allegedly compensated even for enrollment forms where the patient is never approved or goes on the drug. Instead of writing a prescription on a pad, doctors or their staff fax a referral form to initiate the process of getting a patient onto Wakix. Every single former territory manager we interviewed conveyed that the plan was extremely unusual and that they have never seen anything similar. Common sense indicates that the only purpose of such a plan is to incentivize sales reps to proliferate inappropriate patient referral forms: “I’ve never seen a company in my life do that. Never. 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Were you compensated based on the number of cataplexy diagnoses you got?”\nA: “No, you're just compensated based on your scripts.” – Ex-Harmony territory manager for a large region in the southeast across two states", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": null, "subkind": { "name": "Testimonial", "slug": "testimonial", "status": "active", "canonId": "019de52c-fc21-71b6-9ac3-8266a64945e8", "version": 1, "description": null }, "framework": null }, "subkind": "testimonial", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:38.305+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "25ac00fb-3c6a-45a5-9569-b0161b2f5f67", "parentComponentId": null }, { "bbox": { "h": 0.25, "w": 0.86, "x": 0.07, "y": 0.45 }, "kind": "quote", "text": "Comp plan based on faxed referrals was highly unusual and “really weird, really odd”\n“You would have reps that you would hear - like some of the people that are maybe the top five people in the company - and you would hear stories as a rep, and they're just going to that office, they just sent a bunch of stuff through—I don't even care. 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Q: “Was there anything in the compensation plan... that didn't sit right with you?” A: “...it really put pressure on the salesforce... and all of them do it.”", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": null, "subkind": { "name": "Testimonial", "slug": "testimonial", "status": "active", "canonId": "019de52c-fc21-71b6-9ac3-8266a64945e8", "version": 1, "description": null }, "framework": null }, "subkind": "testimonial", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:37.841+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "46bda467-caaa-4d9f-a3d0-edaf180530f5", "parentComponentId": null }, { "bbox": { "h": 0.25, "w": 0.86, "x": 0.07, "y": 0.65 }, "kind": "quote", "text": "Company allegedly sets quotas far in excess of probably narcolepsy patients in a territory: “...the number that Harmony upper management is putting out... makes no sense whatsoever... The numbers never matched up to me.”", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": null, "subkind": { "name": "Testimonial", "slug": "testimonial", "status": "active", "canonId": "019de52c-fc21-71b6-9ac3-8266a64945e8", "version": 1, "description": null }, "framework": null }, "subkind": "testimonial", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:37.841+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "68744703-53f4-4a88-828a-8c1222caa6f3", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "“that kind of pressure...it really put pressure on the salesforce because it incentivizes them to go outside those boundaries – and all of them do it...so ridiculous is how they’re forcing reps to work outside the boundaries of compliance...and all of them do it.” — Ex-Harmony territory manager for a large region in the southeast across two states. “it makes no sense whatsoever...I don’t know what methodology they were using to figure that out...the numbers never matched up.” — Ex-Harmony territory manager for several states in the Northeast", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:50:00+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d1-73a9-abbf-79ecd6f1a3b8", "parentComponentId": null }, { "bbox": { "h": 0.03, "w": 0.3, "x": 0.07, "y": 0.95 }, "kind": "source-note", "text": "Source: Scorpion Capital consultation calls with experts", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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reps indicate they have never seen that kind of comp plan before; rep gets paid “even if no chance in hell that hose are getting filled” or shipped to a patient", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:43.964+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "0d7708a9-f9ec-4835-adae-e1b6e8b03944", "parentComponentId": null }, { "bbox": { "h": 0.48, "w": 0.86, "x": 0.07, "y": 0.41 }, "kind": "paragraph", "text": "A: “You don’t get credit for the refills. You don’t really see that number.”\nQ: “So, what did you make of that?”\nA: “That’s a little weird. The whole sales process there is a little weird because you get credit when the fax goes through the fax machine. Have you been told that before?\nQ: “No.”\nA: “So, you get credit—this is different than any place that I’ve ever worked in my career. And if you ask somebody at Harmony. it sounded like from talking with everybody that, again, it’s kind of weird. So, if you put a fax through the fax machine, and it goes over, and it goes to this hub, and there are three different hubs that they can go to. First of all, it goes to Harmony’s hub. Harmony takes that prescription, they’ll look at it, and they say okay, where do we go to get the script covered? Then Harmony would scrub that prescription, which came in via the fax, and they would take it and send it to whatever specialty pharmacy of those three that they thought had the best chance of covering that medication and to get it for that office and the patient. Once that prescription goes through the fax machine, the rep gets credit for the script. Normally the way that it works is the rep doesn’t get credit for the script until it ships out to the patient, meaning now that medication can be charged and the insurance company has to pay for the medication because it’s been shipped. So now, I’m giving credit to the rep because it’s been shipped. That isn’t how they do it. They give credit when it goes into that specialty hub. That was a little weird. And so, if you had an office that just faxed five in for you and none of those five got filled, that sales rep gets credit for it, even though none of those five got filled. 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I don’t know if this is true, but I think maybe it may come on their earnings calls, they are referencing the number of patients that have formed new starts that were faxed in. So, they’re using that as a bellwether for a proxy for success. In the compensation structure, there is no component of the bonus tied to overall volume. So, the sales consultant have no skin in the game to keep a patient on drug, and, even more importantly, no sales consultant has any transparency or visibility into how many patients are on drug in their territory. 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Now, it’s such a tiny window, and it is so hidden - they’re going to enormous lengths in my mind. And maybe I’m wrong, and maybe there are other companies that do this; I’d never seen it. They’re blinding their sales consultants to patients - basically, they’re investing no energy in the patient staying on drug. None. That’s not a long-term play, it’s just not because any sustainable pharma company knows that it’s as easy to keep a patient on drug as to get a new patient, but these guys seem to be just—not seem—they are focused solely on just new starts and hiding all data from everybody.”\nQ: “And how did your contacts interpret that? Is it that they don’t want the salesforce to get demoralized because most of their patients are dropping off? Or they want to be able to promote a number to Wall Street that, internally, people would say it was kind of nonsense?”\nA: “The person I spoke to specifically gave me these details. 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You have to fill out a special form, and it's all manual, as much as the salesforce fought to get everything digitalized, especially in this world that we're living in post-covid. They just have not done it. But there's a form that has to be filled out manually. It includes all the patient information. It includes the patient insurance information and then includes the office and doctor information. The patient has to sign the form. 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How often do you think that would happen? People aren't stupid. I can tell you the more successful sales reps there were taking advantage of that. And we had pointed it out to our senior leadership and their leadership on numerous—I mean, it doesn't take a whole lot to figure that out.” Q: “And are they just basically lying when a patient doesn't have cataplexy? Like, oh, the patient looks a little stiff or whatever? You just have to make it up to come up with that many scripts - there aren't that many patients with this condition?” A: “Yeah, there are criteria for those two disease states that Wakix has. And you can manipulate those criteria a little bit..I mean, excessive sleepiness is not an indication for Wakix, and I couldn't count how many of those referrals were excessive sleepiness. I couldn't count them. And everyone knew. Everyone knew that.” Q: “They were just writing scripts for excessive sleepiness off-label - anyone has excessive sleepiness if they feel sleepy that day? 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There are just not enough narcolepsy patients out there. What were you chuckling at? 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Or are you making a statement of fact, like you were just shocked that there were this many narcolepsy patients because it's such a rare disease, or you were just genuinely surprised that there were that many, and it was an aha moment? 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I was just surprised, kind of surprised, that every month that these different providers have, or they've identified so many patients. I mean, honestly. Again, we're not talking about an autoimmune disease.\"", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:40.115+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "8763dd5f-485e-4d80-8892-63301de77544", "parentComponentId": null }, { "bbox": { "h": 0.02, "w": 0.86, "x": 0.07, "y": 0.7 }, "kind": "paragraph", "text": "Q: \"It sounds like you're being cynically surprised at the number of patients. Am I interpreting you correctly?\"", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:40.115+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "94fe7c13-ff1a-45d5-a1ee-1cc0e3ef81b8", "parentComponentId": null }, { "bbox": { "h": 0.08, "w": 0.86, "x": 0.07, "y": 0.48 }, "kind": "paragraph", "text": "A: \"I was stunned at how many cataplexy and narcolepsy patients that are legitimately out there. I was stunned. Stunned. I mean, they're not just going to a sleep specialist, they're actually going to DOs, and they're going to MDs, I mean, regular practitioners. I was just amazed, just amazed how many patients that were out there that legitimately or not actually had this disease.\"", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:40.115+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "a37c3830-ab22-43c7-8de2-d55a5bf9727c", "parentComponentId": null }, { "bbox": { "h": 0.04, "w": 0.86, "x": 0.07, "y": 0.73 }, "kind": "paragraph", "text": "A: \"Yeah, I mean, consistently. Week after week, month after month, yes...It's almost like narcolepsy's a pandemic, not a rare disease.\" -Ex-field reimbursement manager working with Harmony", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:40.115+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "e206ae12-5495-404d-8c48-c48aa39efdec", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "I was stunned at how many cataplexy and narcolepsy patients that are legitimately out there. I was stunned. 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regional managers and reps hounded reimbursement staff for information they could use to convert off-label scrips to on-label", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": null, "subkind": { "name": "Primary callout", "slug": "primary", "status": "active", "canonId": "019de52c-fbd1-70eb-a9ce-8997f8674c1d", "version": 1, "description": null }, "framework": null }, "subkind": "primary", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:40.3+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "7ff03328-4f1a-4cf5-a088-19756497e5d5", "parentComponentId": null }, { "bbox": { "h": 0.25, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "He highlighted the aberrant nature of the incentive plan – “this is the only situation I’m aware of in my tenure working in reimbursement” and wondered why the rep is getting paid “for patients that don’t get the drug...no one else is getting paid on that...the pharmacy is not getting paid.” Then he explained why: reps were incentivized to proliferate off-label prescriptions as they could then “go back in and salvage two or three of those patients that were off-label – but my question is, what happened to make from off-label to on-label?...I mean, did the patient suddenly get worse?”", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:40.3+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "8b90302c-f0bd-4666-acc2-f029a294c102", "parentComponentId": null }, { "bbox": { "h": 0.45, "w": 0.86, "x": 0.07, "y": 0.43 }, "kind": "paragraph", "text": "Q: “What’s your commentary on what you think is essentially fraudulent, because that’s basically what you’re describing. And, by the way, you’re not the only person to describe that to me.”\nA: “I would say whenever you’re compensating someone—this is the only situation that I’m aware of in my tenure working in reimbursement, working in contract management, working with Cigna’s and the Aetna’s and even working with the smaller Blues plans and the Medicaid plans...I’m trying to give kind of a global perspective on how one makes this assessment. I mean, you don’t get paid for patients that don’t get the drug. You just don’t. No one else is getting paid on that. The pharmacy is not getting paid.”\nQ: “So, why do they do that? Because they just think they’ll get a certain percentage of those through?”\nA: “I think that’s part of it. Part of the strategy might be that they can go back in and salvage. I mean, people go back in and salvage two or three of those patients that were off-label, hey—but my question is, what happened to make it from off-label to on-label? What happened? 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"parentComponentId": null }, { "bbox": { "h": 0.55, "w": 0.86, "x": 0.07, "y": 0.41 }, "kind": "paragraph", "text": "Q: \"But you or the person above you were essentially interacting with 17 sales reps or territory managers for Harmony?\" A: \"Yeah. I specifically was interacting with 17...\"", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:40.316+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "f60ace8e-366a-47f5-9892-a20cbde143bd", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "“It was a huge red flag - I mean, it just didn't make sense that the salespeople were reimbursed on referrals or prescriptions. Quite a lot of these prescriptions were junk. 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How is it getting through? Where's the weak link in the chain?”\nA: “Going back to the criteria, this is something that [redacted] would push, and [redacted] would want to know, so there are 10 referrals from this doctor. Why are only 5 of these being filled? Well, we had access to that data; they did not. So, they would push me. Well, [redacted], why are only half of these--? Well, because they were off-label? Well, what indications did they put down? Honestly, that's really none of your business what indication. But [redacted] would push for it. I think [redacted] would take that feedback from us, and take that to the rep and then the rep would go in and say, Hey, you remember those 10 referrals you said you put through? Well, only 5 of these were on-label. How can we creatively take a look at those 5 that were off-label, and could they possibly be narcolepsy instead of excessive daytime sleepiness? Could we possibly say that it's this by taking the patient information in such a way--? 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Would you see a bunch of scripts rejected by a prescriber, and then all of a sudden, they're not rejected because they successfully said the right thing? Did you observe that?”\nA: “I could say, yeah. There was always an improvement...honestly, if someone could coach the individuals completing these referral forms on how to be successful with it and how to be creative with it, that would have an immediate impact if it was getting through the payors. The payors would tell you, no, we're not going to approve it because of this piece of criteria that we require is not there. Well, I didn't mention this, then. Oh, I didn't tell you this. Or, I've revised office notes. To answer your question, yes, I've seen offices be progressively more successful in getting Wakix prescribed...you could coach the doctors to say, well, it's not just the doctor. The doctor is not filling out the referral forms normally. You have support staff that does that. The doctor normally does not. So, the doctor should be educated on what those indications are, not how to be creative with the signs and symptoms so it would meet narcolepsy or it would meet cataplexy. But I see that happen. I mean, there were certain reps, and [redacted] was very good at that.”", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:42.153+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "662e9163-cf59-414f-ac96-cfb0c5ede550", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "“In my opinion, that was kind of a strategy that the company might have had from the very, very beginning.” — Ex-field reimbursement manager working with Harmony", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:50:02+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d1-73a9-abc0-662bb74ee114", "parentComponentId": null }, { "bbox": { "h": 0.03, "w": 0.3, "x": 0.07, "y": 0.95 }, "kind": "source-note", "text": "Source: Scorpion Capital consultation calls with experts", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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Sales reps were saying that their manager told the doctor that they’ll only get on the speaker’s program if they write more scripts?”", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:42.029+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "166bd9de-add6-4fbe-97dc-e5daee9f834c", "parentComponentId": null }, { "bbox": { "h": 0.045, "w": 0.854, "x": 0.073, "y": 0.398 }, "kind": "paragraph", "text": "Regional managers were allegedly threatening doctors on the speakers program if they didn’t write enough prescriptions; well-known practice in certain regions, resulting in sales reps leaving the company", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:42.029+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "378cb015-ee90-4d93-8e47-76f534bb503e", "parentComponentId": null }, { "bbox": { "h": 0.075, "w": 0.854, "x": 0.073, "y": 0.666 }, "kind": "paragraph", "text": "Q: “Are you able to say which region that person was in?”\nA: [geographic region redacted]\nQ: “The [geographic region redacted] manager. How many sales managers like that were you interacting with? Was that the only one? Like one bad apple. Or were there a bunch of people like that?”", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:42.029+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "57c9fc36-47f0-4ec8-b017-1f7fa6e8605d", "parentComponentId": null }, { "bbox": { "h": 0.255, "w": 0.854, "x": 0.073, "y": 0.068 }, "kind": "paragraph", "text": "In addition to off-label abuses, he detailed the speaker’s program as a kickback scheme. He alleged that numerous sales reps that he interacted with left Harmony due to their concern – with many voicing their alarm to him personally - and shared examples of regional managers allegedly using the speakers program as a carrot as well as a stick. He stated that speaker who didn’t write enough prescriptions were threatened that “no, you can’t be a speaker for us because you don’t write enough” - or induced with “now, of you write more our drug, I’ll possibly look at making you a speaker.” He added that “you can’t do that...that’s the Stark law.”", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:42.029+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "ac32318f-79fe-4b25-8271-721441764f66", "parentComponentId": null }, { "bbox": { "h": 0.095, "w": 0.854, "x": 0.073, "y": 0.569 }, "kind": "paragraph", "text": "A: “Yup. Or the exact polar opposite. \"You know, you’re currently a speaker with us, but you haven’t been writing as much as you used to. You know what? You may not be a speaker for us much longer if we don’t see these scripts go up because we need our speakers to have a lot more experience with Wakix.\" Now, you can’t do that. You just can’t do that. Did I hear sales managers say that? 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I had sales reps that left Harmony, and they would tell me that their sales manager would be, \"No, you can’t be a speaker for us because you don’t write enough. Now, if you write more of our drug, I’ll possibly look at making you a speaker.\" And you can’t do that. That’s the Stark law. 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given small number of narcolepsy patients, couldn’t hit quota without being “a little creative”", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": { "name": "Visual emphasis", "slug": "visual-emphasis", "status": "active", "bestFor": null, "canonId": "019dd9e1-474b-736b-a8eb-a794dd88241c", "version": 1, "bodyDocId": null, "description": "Drawing the eye to one element above the rest of the slide.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:50:02+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d1-73a9-abc0-f7f3fc188f65", "parentComponentId": null }, { "bbox": { "h": 0.18, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "He characterized the speaker's program as a “leverage tool” over doctors, and stated that the practice was so prevalent that in his region it led to “half of the sales team bring[ing] it to [redacted’s] attention.” He stated in contrast to Harmony, a “compliance issue like that normally is taken very, very seriously.” He emphasized the concerns among the field that led to resignations: “there were other reps that left because of...there were other people that just didn’t like the pressure.”", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:47.204+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "7779f7f4-bbd0-4221-87fd-fe047269c54e", "parentComponentId": null }, { "bbox": { "h": 0.12, "w": 0.86, "x": 0.07, "y": 0.76 }, "kind": "quote", "text": "“...there were other reps that left because of—there were other people that just didn’t like the pressure. We're not talking about rheumatoid arthritis. We're not talking about plaque psoriasis. We're not talking about migraines. There just is not a ton of patients that legitimately have narcolepsy and legitimately have cataplexy; there just aren't. It's a rare disease. Maybe the way they're looking at it, in order for these numbers to be there, you've got to be a little creative.” -Ex-field reimbursement manager working with Harmony", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": null, "subkind": { "name": "Testimonial", "slug": "testimonial", "status": "active", "canonId": "019de52c-fc21-71b6-9ac3-8266a64945e8", "version": 1, "description": null }, "framework": null }, "subkind": "testimonial", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:47.204+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "34ca9444-cdd3-4e30-a961-440f78d88841", "parentComponentId": null }, { "bbox": { "h": 0.18, "w": 0.86, "x": 0.07, "y": 0.5 }, "kind": "quote", "text": "Q: “You were there, and you heard this? Or you heard about it?”\nA: “Whenever half of the sales team brings that to [redacted’s] attention, I mean, we're talking about a sales team of 8 or 10, and half of them are saying that [redacted] is doing that...I've worked for probably some of the larger biotech and pharmaceutical companies out there, and a compliance issue like that normally is taken very, very seriously. Very seriously. That's not something that you do. Doctors are not ignorant. They realize whenever something is—whenever a law is being broken, something like that because I assure you, they don't hear that comment from every pharmaceutical company that comes in and talks to them.”- Ex-field reimbursement manager working with Harmony", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": null, "subkind": { "name": "Testimonial", "slug": "testimonial", "status": "active", "canonId": "019de52c-fc21-71b6-9ac3-8266a64945e8", "version": 1, "description": null }, "framework": null }, "subkind": "testimonial", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:47.204+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "71c47873-7b86-4ebf-83f8-6ba1ce84bece", "parentComponentId": null }, { "bbox": { "h": 0.12, "w": 0.86, "x": 0.07, "y": 0.37 }, "kind": "quote", "text": "A: “We discussed this last time, too. [Redacted] would - there were numerous occasions whenever [redacted] would be in front of a provider and just say, you know, we may have to take you off this lucrative speaker's program because you're just not writing enough. You don't have enough clinical experience with our drug because you're not writing enough of it. Some doctors would take that offensively. And keep in mind, you know, Stark law; you can't do that. You can't provide compensation for speaking based upon—you can't use that as a leverage tool.”", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": null, "subkind": { "name": "Testimonial", "slug": "testimonial", "status": "active", "canonId": "019de52c-fc21-71b6-9ac3-8266a64945e8", "version": 1, "description": null }, "framework": null }, "subkind": "testimonial", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:47.204+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "ab7cbf8b-797a-41d7-83dd-f28272998ae6", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "“We discussed this last time, too. 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I'm confident [redacted] still is...\"", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": null, "subkind": { "name": "Testimonial", "slug": "testimonial", "status": "active", "canonId": "019de52c-fc21-71b6-9ac3-8266a64945e8", "version": 1, "description": null }, "framework": null }, "subkind": "testimonial", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:40.709+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "1d56b117-d7d5-43c7-8e75-f2e5053e5625", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "\"I think there might be three of the original field reimbursement managers there... Out of 15... 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What would happen is their sales reps would push back, and they would just move that sales rep to somewhere else. I'm not kidding. I saw that happen twice because of what they were doing.", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": { "name": "Visual emphasis", "slug": "visual-emphasis", "status": "active", "bestFor": null, "canonId": "019dd9e1-474b-736b-a8eb-a794dd88241c", "version": 1, "bodyDocId": null, "description": "Drawing the eye to one element above the rest of the slide.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:50:02+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d1-73a9-abc0-c820831894a9", "parentComponentId": null }, { "bbox": { "h": 0.18, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "He further alleged that when some sales reps brought the abuses to the company’s attention, the regional managers would simply rotated to other territories: “there were other sales directors like that too, absolutely...what would happen is their sales reps would push back, and they would just move that sales rep to somewhere else. I'm not kidding. I saw that happen twice because of what they were doing.”", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:44.693+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "5b932ea6-ce71-4da0-a841-ebdb0c5cc527", "parentComponentId": null }, { "bbox": { "h": 0.05, "w": 0.86, "x": 0.07, "y": 0.29 }, "kind": "paragraph", "text": "Reps pushing reimbursement staff for info to enable off-label scrips; regional managers pushing this would simply be rotated to other territories if sales reps pushed back", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:44.693+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "7304657e-da42-47bb-b44c-214223106bba", "parentComponentId": null }, { "bbox": { "h": 0.55, "w": 0.86, "x": 0.07, "y": 0.34 }, "kind": "quote", "text": "Q: “What were some of these things that you and other people were getting pressured to do that you weren't comfortable with—ethically or legally or whatever?”\nA: “Providing insight into which of these patients—okay, that patient was off-label, well, what indication did they write? Well, you're not supposed to know that. What was it? It was excessive sleepiness, or it was this indication. Okay, well, so what do they need to do to get--? I don't know. For me to tell you what they have to do to get that patient to cataplexy—”\nQ: “So, you're saying the entire field was basically engaging in this game of trying to push off-label uses and essentially trying to come up with any indication to get the drug approved, which is off-label, essentially.”\nA: “They were just trying to get referrals. That's it. Just trying to get the physicians to write the referral for Wakix. That's what they were getting paid on.”\nQ: “But you're saying that they're willing to do whatever it takes to make that happen?”\nA: “I didn't say all of them. I said there were a few that just - yes. I wasn't comfortable with it.”\nQ: “When you said it wasn't everybody, you're just referring to this one sales manager or were there other bad apples like that?”\nA: “Oh, there were other sales directors like that, too, absolutely. What would happen is their sales reps would push back, and they would just move that sales rep to somewhere else. I'm not kidding. 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\"regulatory nightmare\"", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:43.259+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "1b04b0e7-e626-4412-9adb-b069345fbb37", "parentComponentId": null }, { "bbox": { "h": 0.25, "w": 0.86, "x": 0.07, "y": 0.29 }, "kind": "paragraph", "text": "Q: \"So, do you think one of the reasons why they got rid of Amplity and brought it in-house was because they weren't successful enough in pressuring you guys, so they're trying to get their own internal people to do it?\"\nA: \"Well, I know for a fact they were trying to get their own internal people to do it ...you just have to have that separation of church and state. And if you don't, you're setting yourself up for a regulatory nightmare. I've done buy-and-build drugs, I've done patches, I've done devices, I mean, it has to be segregated, and they're not doing it. They're not going to do it. They're putting them all underneath the same team. I'm telling you, it's going to be a problem. Now, one other thing I will say about the risk with these guys is it's a one-trick pony. I mean, if they ever get in trouble with Wakix, that's all they got to sell. So, if regulatory busts them, if there's a halt, if they can't market it, what are all of these people going to sell? That's all they got. Wakix is it. You know what? I apologize if I'm being a little negative, and I'm not trying to be totally negative.\" - Ex-field reimbursement manager working with Harmony", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:43.259+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "1b4e3741-9560-4aa7-a97f-0660a8736199", "parentComponentId": null }, { "bbox": { "h": 0.03, "w": 0.86, "x": 0.07, "y": 0.55 }, "kind": "paragraph", "text": "\"Surprised\" no regulatory pressure yet; pressure to do whatever it takes to get prescriptions", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:43.259+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "6e131cbc-f3d3-4e52-bd48-d93f88c9dd36", "parentComponentId": null }, { "bbox": { "h": 0.35, "w": 0.86, "x": 0.07, "y": 0.58 }, "kind": "paragraph", "text": "Q: \"The sales reps - are they still at the company?\"\nA: \"No, they all left...yeah, I'm a little surprised there hasn't been—I'm surprised there hasn't been regulatory pressure put on them. I'm surprised.\"\nQ: \"Because of the Stark violations? \"\nA: \"Listen, I've worked for a lot of pharma companies, okay? And I've never seen the goofiness that I've seen with this company.\"\nQ: \"What are some of the other areas of goofiness that we haven't talked about already?\"\nA: \"A lot of it is just the pressure to produce, I mean, very little training, if any training at all, like in [redacted's] case, I mean, [redacted] was so mismanaged. It was just terrible. It was awful. A lot of pressure on sales, a lot of pressure on getting referrals, a lot of pressure on just getting—it was just a lot of pressure. I always kind of attributed that to it being rare and ultra-rare. I mean, how many cataplexy patients are there? Oh my god. How many are there? Get in no matter how you need to get in; get the referrals. I've never seen a company spend so much money on food. I mean, as far as entertaining and speaker's programs, like these guys do. 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A significant number left relatively recently and indicated they receive general market color from former colleagues. They universally painted a picture of a tiny market that Harmony quickly saturated, with the trend hitting a wall 2 years after the 2019 launch. They indicate the sales difficulties worsened in mid-2022 and accelerated recently, as regions ran out of potential patients or doctors failed to see clinical efficacy, and that large numbers of previously successful reps have been placed on PIP’s – Performance Improvement Plans. One ex-sales manager stated that “morale amongst the salesforce is really low...it’s not a happy environment...it’s a pretty sour environment,” and indicated increasing management pressure: “there’s certainly more pressure...I’ve heard that they are struggling.” A second used his territory as an example, stating that his “volume of scripts was steady” but maxed out in mid to late 2021, as there’s a limited number of patients and many don’t want to switch medications, in addition to insurer pressure on doctors.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:46.885+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "11a8d165-0fd7-4507-9aa2-aaff78d2fbc3", "parentComponentId": null }, { "bbox": { "h": 0.25, "w": 0.86, "x": 0.07, "y": 0.7 }, "kind": "quote", "text": "Some regions already peaked in terms of prescriptions in late 2021\nA: “The volume of scripts was steady. Like I said, I had built up a pretty good base on physicians that I could get the 15 prescriptions per quarter. And the territory itself just should have—I don’t know if it has—but should have been able to sustain that. There’s no large amount of patients with excessive daytime sleepiness or cataplexy, and a lot of patients don’t want to convert from a competitor medication to use ours. And then insurance, like I mentioned. So, it’s pretty steady from when I was there. I increased it probably—when I first came in the territory, I was getting anywhere from two to five scripts, and then I gradually built it up to 10 to 15. I think that’s probably where it will probably max out.\nQ: “When did it max out in your territory? What was the point?”\nA: “Probably the second or third quarter of 2021.” – Ex-Harmony territory manager for a large region Florida and another state", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": null, "subkind": { "name": "Testimonial", "slug": "testimonial", "status": "active", "canonId": "019de52c-fc21-71b6-9ac3-8266a64945e8", "version": 1, "description": null }, "framework": null }, "subkind": "testimonial", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:46.885+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "6ab49a8b-679d-4a57-8190-f08461cae165", "parentComponentId": null }, { "bbox": { "h": 0.12, "w": 0.86, "x": 0.07, "y": 0.55 }, "kind": "quote", "text": "“Morale amongst the salesforce is really low”; “heard that they are struggling”\n“I will say, I think for what it’s worth, morale amongst the salesforce is really low...It’s not a happy environment. 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an initial flurry of interest for a new drug followed by reality within two years, as the few doctors willing to try it ran out of patients or soured due to lack of clinical efficacy.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:48.069+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "03bf9e6d-dd33-4bde-bfac-4d5802cf8e59", "parentComponentId": null }, { "bbox": { "h": 0.04, "w": 0.86, "x": 0.07, "y": 0.44 }, "kind": "paragraph", "text": "Whale prescribers cutting prescriptions as they run out of patients or have no clinical results or “heat” from insurers", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:48.069+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "53c0560c-062a-4c4e-b2dc-977c561eddc6", "parentComponentId": null }, { "bbox": { "h": 0.45, "w": 0.86, "x": 0.07, "y": 0.48 }, "kind": "paragraph", "text": "Q: “How many Wakix scripts did he [the only whale prescriber in the territory] write, or how many patients did he have on at a time roughly? And does he still use it? Are you still in touch with him?”\nA: “That launch year, I think he had like 12 patients. So, I think he had like four a quarter. And when we launched, the message was we’ll get your patients that are on medication that are not doing well. So, I think he had 12 the first year, and he had much less the second year because a lot of doctors when a new drug comes out, they’re looking for patients, and then they get through their patient deck, and they’re like, I don’t have any more patients. I’ve tried it on everybody. It was definitely less.”\nQ: “You said he had about 12 the first year. How many did he have the second year?”\nA: “In June, when we launched, he had a couple, and then he picked—I’m going off memory—and then he tapered back. I think he was getting a lot of heat from the insurance company right there at the end of 2020, end of 2021, and he scaled back quite a bit. He was going with about four patients a month, and this is average, just depending. And then it dropped off there at the end when I was leaving there. I think he was getting some pushback, probably from the insurance companies. I don’t think he was seeing the results that he wanted to see from these patients the had put on it.” – Ex-Harmony territory manager for a large southeast region across two states", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:48.069+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "8c6a15a7-1e3c-4756-91d0-57ab1674719f", "parentComponentId": null }, { "bbox": { "h": 0.22, "w": 0.86, "x": 0.07, "y": 0.22 }, "kind": "paragraph", "text": "A third ex-territory manager detailed what occurred in his region. 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They’re just not seeing that many patients...It’s very difficult...we got all the low-hanging fruit.” — Ex-Harmony territory manager for an eastern state", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:50:03+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d1-73a9-abc1-666af4df46c2", "parentComponentId": null }, { "bbox": { "h": 0.02, "w": 0.25, "x": 0.07, "y": 0.95 }, "kind": "source-note", "text": "Source: Scorpion Capital consultation calls with experts", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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We're not going to have more of these patients..", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": null, "subkind": { "name": "Testimonial", "slug": "testimonial", "status": "active", "canonId": "019de52c-fc21-71b6-9ac3-8266a64945e8", "version": 1, "description": null }, "framework": null }, "subkind": "testimonial", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:43.443+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "2a41cf31-82ea-4bb0-a5e2-b248f5bd1759", "parentComponentId": null }, { "bbox": { "h": 0.25, "w": 0.86, "x": 0.07, "y": 0.38 }, "kind": "quote", "text": "It was a bit of a toxic culture...they have instituted things like—I don't know if you've heard the word PIP, but it's a performance incentive plan—it's to increase your performance...The numbers never matched up to me.", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": null, "subkind": { "name": "Testimonial", "slug": "testimonial", "status": "active", "canonId": "019de52c-fc21-71b6-9ac3-8266a64945e8", "version": 1, "description": null }, "framework": null }, "subkind": "testimonial", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:43.443+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "a0e5fb70-5280-48c0-90f9-84c2622abeff", "parentComponentId": null }, { "bbox": { "h": 0.15, "w": 0.86, "x": 0.07, "y": 0.78 }, "kind": "quote", "text": "Q: Has the PIP plan prevalence changed a lot recently? 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And he's a good rep.", "attrs": null, "canon": { "kind": { "name": "Callout", "slug": "callout", "status": "active", "canonId": "019de52c-f8d3-761a-8953-7d37080de5e2", "version": 1, "description": "Highlighted callout box." }, "tool": { "name": "Visual emphasis", "slug": "visual-emphasis", "status": "active", "bestFor": null, "canonId": "019dd9e1-474b-736b-a8eb-a794dd88241c", "version": 1, "bodyDocId": null, "description": "Drawing the eye to one element above the rest of the slide.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:50:04+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d1-73a9-abc2-18eaa07eb999", "parentComponentId": null }, { "bbox": { "h": 0.15, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "Two other ex-territory managers corroborated the recent spike in Performance Improvement Plans, stating that even Harmony’s top territories and performers are now hitting the wall.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:45.341+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "993642cc-c042-4538-9b66-1164fdba038c", "parentComponentId": null }, { "bbox": { "h": 0.15, "w": 0.86, "x": 0.07, "y": 0.67 }, "kind": "quote", "text": "So, it did fall off...my performance did slip off for that quarter, but in previous quarters, I had done well. 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In comparison, 80 with modafinil/armodafinil... 40. Sunosi, 8 times. Amphetamines, 30 times. 15, and the majority of those have been sodium oxybate\"", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": null, "subkind": { "name": "Testimonial", "slug": "testimonial", "status": "active", "canonId": "019de52c-fc21-71b6-9ac3-8266a64945e8", "version": 1, "description": null }, "framework": null }, "subkind": "testimonial", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:44.064+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "40f7cab9-b2e4-4162-b8a4-02d403a4c1c9", "parentComponentId": null }, { "bbox": { "h": 0.15, "w": 0.86, "x": 0.07, "y": 0.75 }, "kind": "quote", "text": "\"Drug really hasn't taken off...and I was somebody who was pretty bullish on it\" \"...it's just not as effective as we wanted it to be. And I was somebody who was pretty bullish on it. I really liked the idea of it.\"", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": null, "subkind": { "name": "Testimonial", "slug": "testimonial", "status": "active", "canonId": "019de52c-fc21-71b6-9ac3-8266a64945e8", "version": 1, "description": null }, "framework": null }, "subkind": "testimonial", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:44.064+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "e59fbda3-44b4-4f47-9b92-7f8060afe21d", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "“my prescribing of Wakix has really started to peter off quite a bit.” ... “it’s just not as effective as we wanted it to be...and I was somebody who was pretty bullish on it...I really liked the idea of it.” — Physician and professor of neurology at a large academic center", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:50:03+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d1-73a9-abc1-d8c97e6572e8", "parentComponentId": null }, { "bbox": { "h": 0.03, "w": 0.3, "x": 0.07, "y": 0.94 }, "kind": "source-note", "text": "Source: Scorpion Capital consultation calls with experts", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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A: “I think Wakix—I don’t know that it’s going to grow much—I don’t know how much it’s going to grow compared to the percentage of the market it already has.” Q: “Do you think it’s kind of saturated and tapped out?” A: “I don’t know if it’s tapped out. I think that any monumental growth that it was going to make probably would have happened by now. I think it’s probably just going to keep doing kind of what it’s been doing. 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A: “I’ve got about safely 30, probably about 40 narcoleptic patients, which is sky-high. That’s probably 10x more than most people.” Q: “How many patients do you have on pitolisant now?” A: “My grand total right now is about five out of 40.” Q: “And was it higher before? Walk me through what your mindset was at the beginning, what changed, and why it’s only five now.” A: “At the beginning, I was never super-excited by it because I heard rumblings out of Europe that it was just an average drug. So, I never heard that it was an amazing drug, to begin with. I didn’t have super-high expectations. I will say that the patients were excited by it initially. Sunosi had come around at the same time, but everyone was excited about Wakix, and because it was just different, I guess. I wasn’t getting the best results...it wasn’t like a wow like they get with Xyrem. For me, the Xyrem is just so effective that it pales in comparison to that. So, I relegated it pretty early on to my Xyrem failures or Xyrem intolerance...My last start on Wakix was probably late last year or early this year. I can’t recall; it’s been a while, and we’re at the end of this year. It’s been almost a year, I have not started anyone.” – Neurologist and professor at a large academic institution", "attrs": null, "canon": { "kind": { "name": "List", "slug": "list", "status": "active", "canonId": "019de52c-f94b-779b-a53b-fd4904a5f4d2", "version": 1, "description": "Bullet or numbered list." }, "tool": null, "subkind": { "name": "Bullet list", "slug": "bullet", "status": "active", "canonId": "019de52c-fc98-7169-a083-5cab805076ca", "version": 1, "description": null }, "framework": null }, "subkind": "bullet", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:45.249+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "e6af5adb-b764-4009-a96d-0cf81ac2dbe7", "parentComponentId": null }, { "bbox": { "h": 0.35, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "A prolific speaker for Harmony who we believe to be one of their top two or three prescribers in the country stated Wakix is tapped out and won’t grow much from here: “I don’t know that it’s going to grow much...compared to the percentage of the market it already had”; “any monumental growth that it was going to make probably would have happened by now...it’s probably just going to keep doing kind of what it’s been doing.” We asked him who Harmony’s largest prescribers are in the US, and he rattled off their names and evinced knowledge of their prescribing patterns, leading us to believe that they share his view that Harmony has hit a wall. 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My last start on Wakix was probably late last year or early this year. I can't recall; it's been a while, and we're at the end of this year. It's been almost a year, I have not started anyone. — Neurologist and professor at a large academic institution", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:50:04+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d1-73a9-abc2-c3d44078eb21", "parentComponentId": null }, { "bbox": { "h": 0.02, "w": 0.25, "x": 0.07, "y": 0.96 }, "kind": "source-note", "text": "Source: Scorpion Capital consultation calls with experts", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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Another at a large center stated that if the Harmony rep wasn’t proactive and bringing lunches that “it would be just dead” in his practice, and that the few patients he has on it are only because he has so many patients who fail other drugs that he threw a few onto Wakix as a Hail Mary.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "5f2affc0-941d-4d07-959d-4bfc1930cea4", "version": 1, "description": "Single prose block in the body of a slide." }, "tool": null, "subkind": { "name": "Paragraph", "slug": "paragraph", "status": "active", "canonId": "019de52c-fb80-75af-aa5c-a7a4bfac2433", "version": 1, "description": null }, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:43.491+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "cb88bef4-6841-4d63-bd6e-4e777752d80d", "parentComponentId": null }, { "bbox": { "h": 0.48, "w": 0.86, "x": 0.07, "y": 0.43 }, "kind": "quote", "text": "“Excitement for this is on the wane”; previously excited doctors now “quite disappointed” ... “I don’t know anybody who’s really bullish on it”; just prescribe “a little bit here or there”; no one “loves” Wakix ... KOL at one of the largest centers in the country has no idea what it costs, VA patients", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": null, "subkind": { "name": "Testimonial", "slug": "testimonial", "status": "active", "canonId": "019de52c-fc21-71b6-9ac3-8266a64945e8", "version": 1, "description": null }, "framework": null }, "subkind": "testimonial", "groupRole": null, "confidence": null, "extraction": { "at": "2026-05-02 20:18:43.491+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "9226d689-daf0-499d-a06e-68df50563654", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "I think the excitement for this is on the wane. The peak excitement was right before we started prescribing it... we were fairly eager and excited, and then quite disappointed by how the burden of prescribing has really interfered with our ability to get people on it. — Physician and professor of neurology at a large academic center", "attrs": null, "canon": { "kind": { "name": "Quote", "slug": "quote", "status": "active", "canonId": "019de52c-f8fb-751e-8bc6-d58e2d59562a", "version": 1, "description": "Pull quote or testimonial." }, "tool": { "name": "Authority citation", "slug": "authority-citation", "status": "active", "bestFor": null, "canonId": "019dd9e1-49ae-7557-89ad-3fca70469b45", "version": 1, "bodyDocId": null, "description": "Quoting an authority figure, study, or precedent to lend weight.", "familyLabel": null }, "subkind": null, "framework": null }, "subkind": null, "groupRole": null, "confidence": null, "extraction": { "at": "2026-04-22 23:50:04+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-64d1-73a9-abc2-56267fb094d1", "parentComponentId": null }, { "bbox": { "h": 0.02, "w": 0.25, "x": 0.07, "y": 0.95 }, "kind": "source-note", "text": "Source: Scorpion Capital consultation calls with experts", "attrs": null, "canon": { "kind": { "name": "Source note", "slug": "source-note", "status": "active", "canonId": "23484952-494b-4a5e-b1ad-550d0d70e948", "version": 1, "description": "Attribution / source / caveat placed at the slide footer. 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