{ "schemaVersion": "deck-intelligence.v1", "id": "019dd923-622c-750b-8b9a-17a662f06f5c", "slug": "883b7cfa22f5", "title": "Harmony Biosciences (HRMY)", "subtitle": "Kir Kahlon · 2023-04", "author": "Kir Kahlon", "date": "2023-04-03 00:00:00", "pageCount": 10, "kind": "regulatory-filing", "orientation": "portrait", "aspectRatio": 0.77272725, "targetCompany": "Harmony Biosciences", "targetTicker": "HRMY", "document": { "id": "019dd923-622c-750b-8b9a-17a662f06f5c", "slug": "883b7cfa22f5", "title": "Harmony Biosciences (HRMY)", "rawTitle": "Citizen Petition", "authorId": "58_Scorpion_Capital", "authorName": "Kir Kahlon", "authorDisplay": "Kir Kahlon", "kind": { "slug": "regulatory-filing", "label": "Regulatory filing" }, "sourceType": { "slug": "short_seller", "label": "Short seller" }, "fileName": "Citizen-Petition.pdf", "sourceUrl": null, "sourceDate": "2023-04-03 00:00:00", "presentationDate": "2023-04-03 00:00:00", "ingestedAt": "2026-04-22 22:21:16+00", "status": "ready", "pageCount": 10, "orientation": "portrait", "aspectRatio": 0.77272725, "targetCompany": "Harmony Biosciences", "targetTicker": "HRMY", "metadata": { "local_root": "/tmp/legacy-images/883b7cfa22f5", "activist_firm": "Scorpion Capital", "origin_corpus": "contrarian", "extraction_seconds": 75.16059517860413 } }, "coverage": { "pageCount": 10, "pagesIndexed": 10, "pagesWithImages": 10, "pagesWithMetadata": 10, "imageCoveragePct": 100, "metadataCoveragePct": 100, "componentCount": 61, "chartCount": 0, "metricSlides": 0, "toolMatches": 4, "documentToolMatches": 3, "frameworkMatches": 4, "arcMatches": 1, "beatMatches": 4, "loopMatches": 2, "patternMatches": 0, "storymakersMatch": false, "scoreAvailable": false, "reviewAvailable": false, "activistThesisAvailable": true, "pitchdeckMetadataAvailable": false, "pitchdeckProfileAvailable": false }, "blocks": [], "matches": { "arcs": [ { "arc": { "name": "Problem-Agitate-Solution", "slug": "problem-agitate-solution", "status": "active", "bestFor": "Sales pitches, urgency-driven, competitive displacement", "canonId": "019dd956-5ec6-70f9-9fd8-fdbaaff39acf", "version": 1, "bodyDocId": "019df22a-2356-73eb-8061-d8c81dc0aa49", "structure": "Problem (Identify pain) -> Agitate (Make it worse) -> Solution (Provide relief)", "description": null, "familyLabel": null, "categoryName": "Strategy & Business", "categorySlug": "strategy-business" }, "matchId": "6207c716-033b-4c99-874c-c2fd5cb3feba", "evidence": "The sequence starts with a critique of Wakix, followed by documentation of concerns and a demand for action", "isPrimary": true, "confidence": 0.8, "extraction": { "at": "2026-07-16 22:01:11.292826+00", "model": "or:meta-llama/llama-4-scout", "runId": null, "seconds": null, "promptVersion": "doc-narrative-v1" } } ], "beats": [ { "to": 4, "arc": { "name": "Problem-Agitate-Solution", "slug": "problem-agitate-solution", "status": "active", "bestFor": "Sales pitches, urgency-driven, competitive displacement", "canonId": "019dd956-5ec6-70f9-9fd8-fdbaaff39acf", "version": 1, "bodyDocId": "019df22a-2356-73eb-8061-d8c81dc0aa49", "structure": "Problem (Identify pain) -> Agitate (Make it worse) -> Solution (Provide relief)", "description": null, "familyLabel": null, "categoryName": "Strategy & Business", "categorySlug": "strategy-business" }, "from": 2, "name": "Complication", "beatId": "b64df291-51b1-4c28-8f3b-791f9f32796e", "matchId": "6207c716-033b-4c99-874c-c2fd5cb3feba", "beatType": { "name": "Complication", "slug": "complication", "status": "active", "canonId": "019dd9b8-0275-7709-b2d6-4f77c3fc7579", "version": 1, "description": "The point in the narrative where the audience should feel discomfort. 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Companion regulatory filing to Scorpion's 366-page short report on Harmony Biosciences (HRMY) published March 28, 2023 — linked in Appendix A. Counts as follow_up to the main short report, but is itself a primary-material regulatory filing using the petition format rather than a deck. CEO-quote-contradiction flag is set because Scorpion quotes Harmony's own key speakers admitting they ignore label warnings (\"those items are just warnings…you don't have to do anything\") and cites Bioprojet's own 2012 paper disproving the histamine-narcolepsy mechanism. No charts, no SOTP — pure prose legal/scientific argument. Visual quality 1: plain Word-style memo.", "kpisCited": [ { "detail": "$175,000 per patient per year vs. ~$10-15/month generic modafinil", "metric": "Annual cost of Wakix" }, { "detail": "13 total deaths, 12 in foreign clinical trials, 100% in drug arm vs. zero in placebo", "metric": "Pre-approval deaths in pitolisant development program" }, { "detail": "38% of participants enrolled in Russia per CDER review", "metric": "Russian enrollment in pivotal HARMONY CTP trial" }, { "detail": "16 Wakix prescribers interviewed; one near-fatality (drug-induced arrhythmia in healthy 42-year-old) found in that small sample", "metric": "Physician interview sample" }, { "detail": "70-year-old male fatal heart attack on first day of titration to 35.6 mg, two weeks after starting Wakix", "metric": "FOIA case ID 21248927" }, { "detail": "Wakix is the first and only approved H3 antagonist/inverse agonist after 2+ decades of major pharma failures", "metric": "FDA H3-class drug approvals" }, { "detail": "9 drugs withdrawn for cardiotoxicity; 2 (terfenadine, astemizole) in the histamine class", "metric": "FDA cardiotoxicity withdrawals" } ], "closingAsk": "Withdraw FDA approval of pitolisant, mandate an Important Drug Warning DHCP letter, impose a REMS-based compassionate-use regime, and convene an Advisory Committee.", "extraction": { "at": "2026-04-22 22:21:16+00", "model": "unknown-legacy", "runId": null, "seconds": 75.1606, "promptVersion": null }, "scqaReward": "Withdrawal would prevent a Seldane-style cascade of preventable cardiac deaths in a vulnerable narcolepsy population, with no public-health loss given that generic modafinil at ~$10/month is the superior standard of care.", "thesisTypes": [ "fraud_exposure" ], "top3Reasons": [ "Pitolisant's H3-receptor class is inherently cardiotoxic via hERG blockade — a Catch-22 with no fix", "FAERS, FOIA case narratives and 13 pre-approval deaths show a super-normal post-marketing safety signal", "Pivotal trials were run in Russia and other low-quality jurisdictions on an unvalidated subjective endpoint (ESS)" ], "scqaSituation": "Wakix (pitolisant), marketed by Harmony Biosciences at $175,000/year, is the first and only FDA-approved histamine H3 receptor antagonist/inverse agonist, indicated for excessive daytime sleepiness and cataplexy in adult narcolepsy.", "thesisSummary": "Scorpion Capital formally petitions the FDA to withdraw approval of Harmony Biosciences' Wakix (pitolisant), the first-ever histamine H3 receptor antagonist/inverse agonist, calling it a regrettable repeat of the Seldane (terfenadine) cardiotoxicity saga. Scorpion documents a fatal heart attack in a 70-year-old two weeks after starting Wakix, an unreported drug-induced arrhythmia in a healthy 42-year-old, 13 pre-approval deaths concentrated in foreign trial arms, and a wave of FAERS adverse events including seizures, hepatitis and pulmonary embolism. The petition argues that hERG blockade is structurally inseparable from H3 binding, that pivotal HARMONY trials enrolling 38% of patients in Russia rely on an unvalidated translated Epworth Sleepiness Scale, and that a $175,000-a-year drug inferior to generic modafinil and used only as a third- or fourth-line add-on has no cost/benefit justification. Scorpion compares the situation to Aduhelm and demands withdrawal, a DHCP warning letter, a REMS regime, and an Ad Comm.", "primaryDemands": [ "Withdraw FDA approval of Wakix (pitolisant) for all current and future indications", "Require Harmony Biosciences to issue a Dear Healthcare Provider Letter (Important Drug Warning) to all Wakix prescribers", "Transition Wakix to a compassionate-use program with a REMS protocol for current patients", "Convene an FDA Advisory Committee to review the safety and efficacy data" ], "scqaResolution": "FDA should withdraw Wakix's approval, force a Dear Healthcare Provider warning letter, transition existing patients to a REMS-controlled compassionate-use program, and convene an Advisory Committee with hERG and H3 experts.", "thesisOneLiner": "Scorpion petitions the FDA to pull Wakix (pitolisant), arguing the H3-receptor drug is inherently cardiotoxic, clinically inferior to $10 modafinil, and approved on fraud-tainted Russian trials.", "precedentsCited": [ "Seldane (terfenadine) FDA withdrawal in 1997 for QT prolongation and torsades de pointes", "Astemizole FDA withdrawal for cardiotoxicity", "Aduhelm — recent CNS approval widely viewed as erroneous", "Two-decade 100% failure rate of H3-receptor programs across major pharma" ], "scqaComplication": "H3 antagonists are structurally inseparable from hERG blockade and cardiotoxicity; FAERS reports, FOIA case narratives, a recent fatality and 13 pre-approval deaths in Russian-led trials reveal a super-normal post-marketing safety signal.", "narrativeInterest": 4, "notableSlidePages": [ 1, 2, 5, 7 ], "peerCompaniesCited": [ "Bioprojet" ], "valuationFrameworks": [ "not_shown" ], "visualCraftInterest": 1 }, "pitchdeck": { "metadata": null, "profile": null }, "slides": [ { "page": 1, "type": "appendix", "title": "This is a formal legal/regulatory document cover letter/introductory page.", "function": "frame_problem", "imagePath": "https://imgproxy.kitesheet.com/-2kI9Y91QimuRCnOJiwwiWpSkwPXdPX5fi5bBffq8TM/rs:fit:1200:1200:0/q:82/f:webp/czM6Ly9raXRlc2hlZXQvY29ycHVzL3NsaWRlcy84ODNiN2NmYTIyZjUvcDAwMS5wbmc", "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": "frame_problem", "functionCanon": { "name": "Frame problem", "slug": "frame_problem", "status": "active", "canonId": "019de52d-13db-753e-ad70-e9b2d0dab398", "version": 1, "description": null }, "density": "dense", "densityScore": 61, "componentCount": 5, "textChars": 914, "nDataPoints": 0, "notes": "This is a formal legal/regulatory document cover letter/introductory page.", "elementsJson": [ "paragraph" ], "confidence": 1, "extraction": { "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "at": "2026-05-02 20:21:57.904+00", "seconds": 3.163, "promptVersion": "v2-canon-conditioned" } }, "links": { "slide": "/slides/019dd923-622c-750b-8b9a-17a662f06f5c/1", "deck": "/decks/019dd923-622c-750b-8b9a-17a662f06f5c", "deckAnchor": "/decks/019dd923-622c-750b-8b9a-17a662f06f5c#slide-1", "deckJson": "/decks/019dd923-622c-750b-8b9a-17a662f06f5c.json" }, "components": [ { "bbox": null, "kind": "callout", "text": "Petitioner is therefore requesting that the FDA withdraw approval of Wakix (pitolisant) and undertake additional remedies, as detailed infra (Section A: Action Requested).", "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 23:20:13+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-14dd-72ca-b98f-5b2ba40cfdf0", "parentComponentId": null }, { "bbox": { "h": 0.2, "w": 0.78, "x": 0.11, "y": 0.7 }, "kind": "paragraph", "text": "While a number of older drugs have hERG/QT liability, it is unusual to see a new drug come to market with pitolisant's flagrant cardiotoxicity... 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The deaths were briefly summarized in a table in the CDER review but otherwise dismissed – a grave error.", "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 23:20:14+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-14dd-72ca-b990-b5557e6b5211", "parentComponentId": null }, { "bbox": { "h": 0.35, "w": 0.72, "x": 0.14, "y": 0.6 }, "kind": "list", "text": "A 57-year old male patient on pitolisant who experienced “seizures and blacking out.” ... A male patient of unreported age ... A 25-year old male patient ... A 27-year old female ... An 18-year old male ... A 42-year old female", "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 20:21:57.935+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "8750fbd9-952d-4fe5-aa00-e39f3bfe4aad", "parentComponentId": null }, { "bbox": { "h": 0.15, "w": 0.72, "x": 0.14, "y": 0.09 }, "kind": "paragraph", "text": "physician indicated that he had 10 patients on Wakix; all but 2 discontinued after he alerted them to the adverse event. We note key features of the 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 20:21:57.935+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "8f151824-4219-4a80-94f0-5a48f355f723", "parentComponentId": null }, { "bbox": { "h": 0.05, "w": 0.72, "x": 0.14, "y": 0.54 }, "kind": "paragraph", "text": "Petitioner notes a number of other troubling case narratives, obtained via FOIA. A few are highlighted 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 20:21:57.935+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "c8902fa9-bbab-4eac-b899-f4dbb8271a07", "parentComponentId": null }, { "bbox": { "h": 0.13, "w": 0.72, "x": 0.14, "y": 0.4 }, "kind": "paragraph", "text": "Nonetheless, the deaths are notable for two reasons. First, 100% of the fatalities were in patients on the drug and none in the placebo arms...", "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 20:21:57.935+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "e00c4573-3685-425b-ac5b-523b7abbfc17", "parentComponentId": null }, { "bbox": { "h": 0.15, "w": 0.72, "x": 0.14, "y": 0.24 }, "kind": "paragraph", "text": "Thirteen deaths during the pitolisant development program, in the pre-approval period, of which 12 occurred in the foreign 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 20:21:57.935+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "eb072943-83b6-4c45-a6e5-b2d237852152", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "The postmarketing data should also be monitored for sudden deaths and cardiovascular and respiratory adverse reactions. — Petitioner", "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 23:20:14+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-14dd-72ca-b990-b88a946e5307", "parentComponentId": null } ], "metrics": [], "tools": [], "frameworks": [ { "matchId": "b93e4805-d001-4eb8-be6e-5a799a67f33a", "evidence": "The slide explicitly alleges 'cover up' attempts and 'cherry-picking' of data to mislead regulators.", "framework": null, "confidence": 0.9, "extraction": { "at": "2026-05-02 20:21:57.935+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "pageNumber": 3, "frameworkName": "fraud-exposure" } ], "arcBeats": [ { "to": 4, "arc": { "name": "Problem-Agitate-Solution", "slug": "problem-agitate-solution", "status": "active", "bestFor": "Sales pitches, urgency-driven, competitive displacement", "canonId": "019dd956-5ec6-70f9-9fd8-fdbaaff39acf", "version": 1, "bodyDocId": "019df22a-2356-73eb-8061-d8c81dc0aa49", "structure": "Problem (Identify pain) -> Agitate (Make it worse) -> Solution (Provide relief)", "description": null, "familyLabel": null }, "from": 2, "name": "Complication", "beatId": "b64df291-51b1-4c28-8f3b-791f9f32796e", "matchId": "6207c716-033b-4c99-874c-c2fd5cb3feba", "beatType": { "name": "Complication", "slug": "complication", "status": "active", "canonId": "019dd9b8-0275-7709-b2d6-4f77c3fc7579", "version": 1, "description": "The point in the narrative where the audience should feel discomfort. 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Lab tests for viral causes were negative, suggesting it may be drug-induced. A 62-year old female patient who was hospitalized with a “life-threatening” pulmonary embolism fifteen days after the first dose of pitolisant. The drug was discontinued and the embolism resolved within 13 days.", "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": "2026-07-17 03:29:00.56+00", "model": "google/gemini-3.1-flash-lite-preview", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "aa0172d3-c7f8-435e-b3e0-811bdf22c7f9", "parentComponentId": null }, { "bbox": { "h": 0.12, "w": 0.78, "x": 0.11, "y": 0.38 }, "kind": "paragraph", "text": "Ominously, numerous studies indicate that within the histamine class, the H3 receptor sub-class – of which pitolisant is the first and only approved drug – is particularly cardiotoxic, as its structure contains a piperidine ring and other features that are the top predictor of hERG liability in drug screens.", "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 03:29:00.56+00", "model": "google/gemini-3.1-flash-lite-preview", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "05ed6953-486e-432d-8658-cf7f23826201", "parentComponentId": null }, { "bbox": { "h": 0.1, "w": 0.78, "x": 0.11, "y": 0.65 }, "kind": "paragraph", "text": "In addition, Petitioner details troubling prima facie flaws in the clinical trials upon which pitolisant’s approval was based. The trials were primarily conduced in questionable foreign jurisdictions, with one of the pivotal trials (HARMONY CTP) enrolling 38% of its participants in Russia, per a table in the CDER 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": null, "framework": null }, "subkind": "paragraph", "groupRole": null, "confidence": null, "extraction": { "at": "2026-07-17 03:29:00.56+00", "model": "google/gemini-3.1-flash-lite-preview", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "28c2be00-b966-4d6c-8f7b-99fe1c9bf59c", "parentComponentId": null }, { "bbox": { "h": 0.12, "w": 0.78, "x": 0.11, "y": 0.25 }, "kind": "paragraph", "text": "These adverse events are not surprising, and were in fact entirely predictable pre-approval. As Petitioner documents in the report, histamine receptor antagonists like pitolisant have a uniquely risky molecular structure with a long history of cardiotoxicity and FDA recalls, due to hERG channel blockade and the potential to cause sudden death via QT prolongation and arrhythmia.", "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 03:29:00.56+00", "model": "google/gemini-3.1-flash-lite-preview", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "71c09882-dcf6-4aee-97cf-5fd4089dde10", "parentComponentId": null }, { "bbox": { "h": 0.12, "w": 0.78, "x": 0.11, "y": 0.51 }, "kind": "paragraph", "text": "Petitioner documents numerous other concerns in the report. For example, Bioprojet, the developer of pitolisant which is alternately listed in the NDA review documents along with Harmony Biosciences as the Sponsor, published a paper in 2012 that unequivocally disproves any association between histamine levels and hypersomnia conditions such as narcolepsy, excessive daytime sleepiness, cataplexy, and others.", "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 03:29:00.56+00", "model": "google/gemini-3.1-flash-lite-preview", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "abb066f7-2433-4f2c-859f-0af75b224bf4", "parentComponentId": null }, { "bbox": { "h": 0.12, "w": 0.78, "x": 0.11, "y": 0.83 }, "kind": "paragraph", "text": "Petitioner’s report notes that the foundation of each clinical trial that led to FDA approval was the Epworth Sleepiness Scale (ESS), by which the primary endpoint of EDS reduction was assessed. 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Withdraw FDA approval of pitolisant for all current and future indications.", "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 23:20:14+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-14dd-72ca-b990-27d6e0ce585e", "parentComponentId": null }, { "bbox": { "h": 0.28, "w": 0.77, "x": 0.116, "y": 0.468 }, "kind": "list", "text": "1. Withdraw FDA approval of pitolisant for all current and future indications. 2. Require Harmony Biosciences to distribute an immediate alert to all Wakix prescribers. 3. Transition Wakix to a compassionate use program in conjunction with a REMS protocol.", "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 21:26:53.963+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "b5784476-6127-43ec-884a-9cae52d1de6e", "parentComponentId": null }, { "bbox": { "h": 0.112, "w": 0.77, "x": 0.116, "y": 0.782 }, "kind": "paragraph", "text": "Petitioner believes it may be helpful for the FDA to convene an Ad Comm to discuss the issues raised in the attached report as well as the actions requested in this Citizen Petition.", "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 21:26:53.963+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "5bbd6cc7-6157-4629-9e2e-dce0b42eae58", "parentComponentId": null }, { "bbox": { "h": 0.014, "w": 0.435, "x": 0.116, "y": 0.441 }, "kind": "paragraph", "text": "This petition requests that the FDA take the following actions:", "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 21:26:53.963+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "6e024c84-f06b-4310-b9a8-506b035fe81d", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "Your application for Wakix was not referred to an FDA advisory committee because the application did not raise significant safety or efficacy issues that were unexpected for a drug in the intended population. — FDA NDA approval letter", "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 23:20:14+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-14dd-72ca-b990-29d094ec8186", "parentComponentId": null }, { "bbox": { "h": 0.018, "w": 0.155, "x": 0.116, "y": 0.412 }, "kind": "title", "text": "A. 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Certification\nThe undersigned certifies that, to the best knowledge and belief of the undersigned, this petition includes all the information and views on which the petition relies, and that it includes representative data and information known to the petitioner which are unfavorable to the petition.", "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 20:21:58.911+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "50db7f8f-0c3b-46cc-aa7a-4b403978d28f", "parentComponentId": null }, { "bbox": { "h": 0.05, "w": 0.77, "x": 0.118, "y": 0.094 }, "kind": "paragraph", "text": "D. Economic Impact\nPursuant to 21 C.F.R. § 10.30(b), economic impact information will be submitted by the Petitioner only upon request of the Commissioner following review of this Petition.", "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 20:21:58.911+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "63cfd67d-035a-4351-8784-ae376429fab8", "parentComponentId": null }, { "bbox": { "h": 0.22, "w": 0.38, "x": 0.118, "y": 0.263 }, "kind": "paragraph", "text": "Respectfully submitted,\nKir Kahlon\n\nKir Kahlon\nFounder and Chief Investment Officer\nScorpion Capital LLC\nkir@scorpioncapital.com\n\nc/o John H. Sutter\nPugsley Wood LLP\n53 State Street, Suite 500\nBoston, MA 02109", "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 20:21:58.911+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "eceed1ef-82a9-4cc0-96b2-84b3a6d91bf0", "parentComponentId": null } ], "metrics": [], "tools": [], "frameworks": [], "arcBeats": [ { "to": 9, "arc": { "name": "Problem-Agitate-Solution", "slug": "problem-agitate-solution", "status": "active", "bestFor": "Sales pitches, urgency-driven, competitive displacement", "canonId": "019dd956-5ec6-70f9-9fd8-fdbaaff39acf", "version": 1, "bodyDocId": "019df22a-2356-73eb-8061-d8c81dc0aa49", "structure": "Problem (Identify pain) -> Agitate (Make it worse) -> Solution (Provide relief)", "description": null, "familyLabel": null }, "from": 8, "name": "Appendix Disclosure", "beatId": "af923635-c0a5-49bf-a664-29be7191488f", "matchId": "6207c716-033b-4c99-874c-c2fd5cb3feba", "beatType": null, "evidence": "Environmental and Economic Impact disclosures", "position": 3, "isPrimaryArc": true, "parentBeatType": null, "alignedBlockIds": null, "matchConfidence": 0.8 } ], "loops": [], "locked": true }, { "page": 10, "type": "appendix", "function": "appendix", "rawType": "appendix", "block": null, "metadata": { "slideType": "appendix", "slideTypeCanon": { "name": "Appendix", "slug": "appendix", "status": "active", "canonId": "019de52d-0762-71f8-b564-89ab863301cc", "version": 1, "description": null }, "function": "appendix", "functionCanon": { "name": "Appendix", "slug": "appendix", "status": "active", "canonId": "019de52d-138d-750b-83c3-49b4bc7a7a38", "version": 1, "description": null }, "density": "sparse", "densityScore": 18, "componentCount": 3, "textChars": 155, "nDataPoints": 0, "notes": null, "elementsJson": [ "paragraph" ], "confidence": 1, "extraction": { "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "at": "2026-05-02 20:22:00.636+00", "seconds": 4.182, "promptVersion": "v2-canon-conditioned" } }, "links": { "slide": "/slides/019dd923-622c-750b-8b9a-17a662f06f5c/10", "deck": "/decks/019dd923-622c-750b-8b9a-17a662f06f5c", "deckAnchor": "/decks/019dd923-622c-750b-8b9a-17a662f06f5c#slide-10", "deckJson": "/decks/019dd923-622c-750b-8b9a-17a662f06f5c.json" }, "components": [ { "bbox": { "h": 0.018, "w": 0.525, "x": 0.118, "y": 0.121 }, "kind": "paragraph", "text": "Petitioner's investigative report dated March 28, 2023. PDF link for public download:", "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 20:22:00.636+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "3a9a8354-1879-448a-b27f-ac9329c9f7ca", "parentComponentId": null }, { "bbox": { "h": 0.018, "w": 0.435, "x": 0.118, "y": 0.149 }, "kind": "paragraph", "text": "https://scorpionreports.s3.us-east-2.amazonaws.com/HRMY1.pdf", "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 20:22:00.636+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "56e3afdc-216b-4be0-84a6-a76e8e286726", "parentComponentId": null }, { "bbox": { "h": 0.018, "w": 0.085, "x": 0.118, "y": 0.093 }, "kind": "title", "text": "Appendix A", "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 20:22:00.636+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "4eacf919-c2af-4d73-9d06-b7a98f12f55e", "parentComponentId": null } ], "metrics": [], "tools": [], "frameworks": [], "arcBeats": [], "loops": [], "locked": true } ], "arcBeats": [ { "from": 2, "to": 4, "label": "Complication", "description": "Petitioner critiques Wakix and documents concerns" }, { "from": 5, "to": 6, "label": "Evidence", "description": "Petitioner provides grounds and supporting documentation" }, { "from": 7, "to": 7, "label": "Executive Summary", "description": "Background on Petitioner and Report" }, { "from": 8, "to": 9, "label": "Appendix Disclosure", "description": "Environmental and Economic Impact disclosures" } ], "loops": [ { "from": 2, "to": 4, "label": "Pattern Hunter", "description": "Establishing a pattern of concern with pharmaceutical products like Wakix" }, { "from": 5, "to": 6, "label": "Cost Of Inaction", "description": "Highlighting the potential consequences of not taking action against Wakix" } ] }