{ "schemaVersion": "deck-intelligence.v1", "id": "019dd923-622c-750b-8b9a-36086e11ebef", "slug": "85d06cb9f231", "title": "Soleno Therapeutics (SLNO)", "subtitle": "Kir Kahlon · 2025-08", "author": "Kir Kahlon", "date": "2025-08-21 00:00:00", "pageCount": 10, "kind": "regulatory-filing", "orientation": "portrait", "aspectRatio": 0.77272725, "targetCompany": "Soleno Therapeutics", "targetTicker": "SLNO", "document": { "id": "019dd923-622c-750b-8b9a-36086e11ebef", "slug": "85d06cb9f231", "title": "Soleno Therapeutics (SLNO)", "rawTitle": "SLNO.CP", "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": "SLNO.CP.pdf", "sourceUrl": null, "sourceDate": "2025-08-21 00:00:00", "presentationDate": "2025-08-21 00:00:00", "ingestedAt": "2026-04-22 22:29:49+00", "status": "ready", "pageCount": 10, "orientation": "portrait", "aspectRatio": 0.77272725, "targetCompany": "Soleno Therapeutics", "targetTicker": "SLNO", "metadata": { "local_root": "/tmp/legacy-images/85d06cb9f231", "activist_firm": "Scorpion Capital", "origin_corpus": "contrarian", "extraction_seconds": 118.3510971069336 } }, "coverage": { "pageCount": 10, "pagesIndexed": 10, "pagesWithImages": 10, "pagesWithMetadata": 10, "imageCoveragePct": 100, "metadataCoveragePct": 100, "componentCount": 60, "chartCount": 0, "metricSlides": 0, "toolMatches": 4, "documentToolMatches": 3, "frameworkMatches": 6, "arcMatches": 1, "beatMatches": 5, "loopMatches": 0, "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": "346c0a43-8a83-467d-8dae-fb1e23374cea", "evidence": "The sequence of slides moves from exposing contradictions and concerns, to agitating the problem by highlighting inadequate warnings, and finally to proposing a solution by requesting regulatory action.", "isPrimary": true, "confidence": 0.8, "extraction": { "at": "2026-07-17 03:21:08.58741+00", "model": "or:meta-llama/llama-4-scout", "runId": null, "seconds": null, "promptVersion": "doc-narrative-v1" } } ], "beats": [ { "to": 5, "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": "Problem & Complication", "beatId": "69f60f3b-27cc-471c-aa78-ba0d72634363", "matchId": "346c0a43-8a83-467d-8dae-fb1e23374cea", "beatType": { "name": "Problem & Complication", "slug": "consultants-gambit-problem-complication", "status": "active", "canonId": "019dd9b8-064a-777f-a374-e9a8c43dedd4", "version": 1, "description": null }, "evidence": "Slides expose contradictions and highlight significant concerns regarding Soleno’s publications.", "position": 0, "isPrimaryArc": true, "parentBeatType": { "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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A CEO-quote-contradiction slide is quotable,\n which means it lands in WSJ/FT/Bloomberg coverage.", "antipattern": null, "cardinality": null, "narrativePurpose": null }, { "tool": { "name": "Villain naming", "slug": "villain-naming", "status": "active", "bestFor": "When governance or specific decisions are the core thesis", "canonId": "019dd9e1-55a4-74db-9314-0ced4cd46cd2", "version": 1, "bodyDocId": "019dd9a1-88f1-72ad-8f4e-56ec29d7b369", "description": "You identify a **specific person** responsible for the target's underperformance\nor the behaviour you want changed — and name them. Not \"management\" or \"the\nboard\". A named executive or director with a specific failure attributable to\nthem.", "familyLabel": null, "categoryName": null, "categorySlug": null }, "agent": null, "layer": "document", "agents": null, "matchId": "ea38b06f-b31c-4dac-b971-b2aa383981c0", "evidence": "Soleno Therapeutics management (CEO referenced but not named); Jennifer Miller and Neal Cowen cited re: DEXA/LBM publication", "pageRefs": null, "priority": null, "whenToUse": "When governance or specific decisions are the core thesis", "confidence": null, "extraction": { "at": "2026-04-29 12:07:50.209813+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "pageNumber": null, "whyItWorks": "- **Accountability needs a face.** Voters (shareholders, regulators,\n journalists) act faster against people than institutions.\n- **Credibility rises with specificity.** \"The CFO has repeatedly missed\n guidance\" > \"Management has missed guidance\".\n- It **pre-empts evasion**. An individual can be removed; an abstraction\n cannot.\n- It **forces the target to respond personally** — and their defensive\n response usually generates more attention for your thesis.", "antipattern": null, "cardinality": null, "narrativePurpose": null }, { "tool": { "name": "Villain slide", "slug": "villain-slide", "status": "active", "bestFor": "In activist decks where the personality matters", "canonId": "019dd9e1-518c-7404-976a-5be5a517b659", "version": 1, "bodyDocId": null, "description": "A dedicated slide presenting the named villain visually", "familyLabel": null, "categoryName": null, "categorySlug": null }, "agent": null, "layer": "document", "agents": null, "matchId": "d0057886-2bcb-44b9-92bc-03d4fa6bced3", "evidence": null, "pageRefs": null, "priority": null, "whenToUse": "In activist decks where the personality matters", "confidence": null, "extraction": { "at": "2026-04-29 12:07:50.209813+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "pageNumber": null, "whyItWorks": "Makes the antagonist concrete", "antipattern": null, "cardinality": null, "narrativePurpose": null }, { "tool": { "name": "Problem-Agitate-Solve (PAS)", "slug": "problem-agitate-solve-pas", "status": "active", "bestFor": null, "canonId": "019dd956-869f-7564-8d42-de54ed29ab90", "version": 1, "bodyDocId": null, "description": "Identify problem, agitate the pain, present the solution", "familyLabel": null, "categoryName": "Block", "categorySlug": "block" }, "agent": "Storyteller", "layer": "slide", "agents": [ "Storyteller" ], "matchId": "a0d7d3e3-257b-427c-a5f7-1781fa809125", "evidence": "The slide presents a problem (the warning is woefully inadequate), agitates it (by highlighting the risks of fluid retention), and implies a solution (recall of VYKAT XR).", "pageRefs": null, "priority": null, "whenToUse": null, "confidence": 0.7, "extraction": { "at": "2026-07-16 23:10:06.387955+00", "model": "or:meta-llama/llama-4-scout", "runId": null, "seconds": null, "promptVersion": null }, "pageNumber": 4, "whyItWorks": null, "antipattern": null, "cardinality": null, "narrativePurpose": null } ], "frameworks": [ { "matchId": "c3b7c57e-9579-4cb3-8822-71dc379b52e5", "evidence": "The text systematically exposes contradictions between company statements and reported safety data.", "framework": null, "confidence": 0.85, "extraction": { "at": "2026-05-02 20:14:35.602+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "pageNumber": 2, "frameworkName": "fraud-exposure" }, { "matchId": "6ae09fc1-2914-4269-8807-cd884950d422", "evidence": "The slide explicitly argues that the company is obfuscating safety data to hide a crisis.", "framework": null, "confidence": 0.85, "extraction": { "at": "2026-05-02 21:26:28.24+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "pageNumber": 3, "frameworkName": "fraud-exposure" }, { "matchId": "1380f0aa-8029-4b5c-9b91-1d8720a0b39c", "evidence": "The slide systematically dismantles the counter-argument that diuretics could solve the safety issues of the drug.", "framework": null, "confidence": 0.9, "extraction": { "at": "2026-05-02 20:14:38.336+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "pageNumber": 4, "frameworkName": "preempt_rebuttal" }, { "matchId": "ef0d78c1-f165-479c-b7ba-ffc930504177", "evidence": "The slide explicitly accuses the subject of obscuring data and scientific misconduct.", "framework": null, "confidence": 0.9, "extraction": { "at": "2026-05-02 20:14:36.182+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "pageNumber": 5, "frameworkName": "fraud-exposure" }, { "matchId": "b4121372-d218-4dbc-870c-1f8b2603f913", "evidence": "The document systematically challenges clinical data integrity and transparency.", "framework": null, "confidence": 0.9, "extraction": { "at": "2026-05-02 20:14:36.628+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "pageNumber": 6, "frameworkName": "fraud-exposure" }, { "matchId": "94b34385-710e-4533-9546-9da76183b195", "evidence": "The slide systematically dismantles the clinical trial evidence used for FDA approval to justify a recall request.", "framework": null, "confidence": 0.9, "extraction": { "at": "2026-05-02 20:14:36.77+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "pageNumber": 7, "frameworkName": "preempt-rebuttal" } ], "patterns": [] }, "storymakers": null, "score": null, "review": null, "activistThesis": { "tone": "adversarial", "notes": "Short companion to Scorpion's 415-page SLNO1 investigative report (Aug 15, 2025). Submitted as FDA Citizen Petition on Aug 21, 2025 — a regulatory-pressure tactic alongside the public short thesis. Pure-text letter format, no charts or branding. Signatory is Kir Kahlon, Scorpion's founder/CIO. Primary rhetorical moves: (1) CEO-quote contradiction — Aug 6 earnings call denial of new safety signals vs 7 hospitalizations disclosed Aug 18 in Guggenheim note; (2) literature-based argument that diuretics/monitoring cannot mitigate diazoxide-induced fluid retention; (3) data-integrity allegations — mismatched edema figures between FDA label and Phase 3 paper, buried ECG results, unpublished withdrawal study, suspicious last-minute p=0.049. Precedent-chains to prior Scorpion petitions (Harmony/Wakix 2023; TransMedics 2025) to establish credibility with FDA. No stake disclosed and no explicit price target — campaign outcome in progress as of filing date.", "kpisCited": [ { "detail": "7 SAE hospitalizations out of inferred ~135 patients on commercial VYKAT XR (~5.2% AE-related discontinuation rate implies denominator)", "metric": "Post-launch hospitalizations" }, { "detail": "27% drug (n=84) vs 12% placebo (n=42)", "metric": "Edema rate (FDA Medication Guide)" }, { "detail": "20.2% drug vs 9.5% placebo — materially lower than the label figures from the same study", "metric": "Edema rate (Phase 3 peer-reviewed paper)" }, { "detail": "30.4% of patients, avg age 13.4 years — rising with duration, no plateau", "metric": "Edema rate in open-label extension (C602)" }, { "detail": "33% PH and 40% respiratory failure over 5 years vs 2-7% in prior literature", "metric": "Diazoxide-induced pulmonary hypertension (Desai 2021)" }, { "detail": "82.4% of participants on GH — synergistically increases fluid-retention risk", "metric": "Growth hormone co-use in P3 extension" }, { "detail": "p=0.049 at week 12 driven by last-4-week HQ-CT placebo spike (+4.5 pbo vs +0.4 drug), 77 patients, 16 weeks, no peer-reviewed publication", "metric": "Randomized-withdrawal study p-value" }, { "detail": "~16 lb linear increase — Scorpion argues this is fluid misattributed as LBM", "metric": "DEXA-inferred lean body mass gain over 3 years" } ], "closingAsk": "Scorpion asks the FDA to request a voluntary recall of VYKAT XR, issue a public health advisory, and convene an Ad Comm to prevent further pediatric hospitalizations.", "extraction": { "at": "2026-04-22 22:29:49+00", "model": "unknown-legacy", "runId": null, "seconds": 118.3511, "promptVersion": null }, "scqaReward": "Removing VYKAT XR from market prevents further pediatric ICU admissions and potential fatalities from congestive heart failure; implicitly, Soleno's equity value — entirely dependent on VYKAT XR — would collapse, rewarding Scorpion's short position.", "thesisTypes": [ "fraud_exposure" ], "top3Reasons": [ "7 hospitalizations out of ~135 patients within weeks of launch signals a post-marketing crisis", "Diazoxide-induced fluid retention cannot be mitigated by diuretics — only discontinuation works", "Label edema data (27%/12%) contradicts Phase 3 paper (20.2%/9.5%), suggesting data misconduct" ], "scqaSituation": "VYKAT XR is Soleno's first-ever drug launch, FDA-approved March 2025 for hyperphagia in Prader-Willi syndrome; Soleno is a 131-employee company with ~135 commercial patients on drug.", "thesisSummary": "Scorpion Capital formally petitions the FDA to recall Soleno Therapeutics' VYKAT XR (diazoxide choline ER), approved March 2025 for Prader-Willi hyperphagia. Within weeks of launch, seven patients — an estimated ~135 total on drug — have been hospitalized for pulmonary/cardiac complications, including an 11-year-old who spent seven weeks in the hospital with a week on a ventilator. Scorpion argues diazoxide mechanistically causes fluid retention that monitoring, slower titration, and diuretics cannot prevent; only discontinuation works, per Desai 2021 and Timlin 2017. The firm also alleges Soleno obscures the signal: edema rates in the FDA label (27%/12%) contradict the Phase 3 paper (20.2%/9.5%), DEXA scans conflate fluid with lean body mass, ECG results are buried, and the 77-patient withdrawal study's last-minute p=0.049 strains credibility. The petition demands recall, a public health advisory, and an Ad Comm.", "primaryDemands": [ "FDA request a voluntary recall of VYKAT XR from the US market", "FDA issue a formal public health advisory to prescribers, patients, caregivers", "FDA take additional regulatory/enforcement actions (e.g. compassionate use + REMS)", "FDA convene an Advisory Committee to review VYKAT XR's safety and efficacy" ], "scqaResolution": "FDA should request a voluntary market recall of VYKAT XR, issue a public health advisory to prescribers and caregivers, and convene an Advisory Committee with PWS trial investigators to review the drug's safety and efficacy.", "thesisOneLiner": "Scorpion petitions FDA to recall Soleno's VYKAT XR after 7 hospitalizations for fluid overload/potential heart failure in children and alleged safety-data manipulation invalidate the drug's risk-benefit.", "precedentsCited": [ "Scorpion 2023 Citizen Petition on Harmony Biosciences / Wakix (pitolisant)", "Scorpion 2025 Citizen Petition on TransMedics Organ Care System", "Desai et al 2021 (diazoxide NICU safety review)", "Timlin et al 2017 (diazoxide pulmonary hypertension case series)" ], "scqaComplication": "Seven pediatric hospitalizations for pulmonary/cardiac fluid-overload events have emerged within weeks of launch; diazoxide-induced edema is non-dose-dependent, cannot be mitigated by diuretics or monitoring, and Soleno's safety disclosures appear manipulated.", "narrativeInterest": 4, "notableSlidePages": [ 1, 3, 5, 7 ], "peerCompaniesCited": [], "valuationFrameworks": [ "not_shown" ], "visualCraftInterest": 1 }, "pitchdeck": { "metadata": null, "profile": null }, "slides": [ { "page": 1, "type": "setup", "title": "This is a regulatory filing document (Citizen Petition) formatted as a letter.", "function": "front_matter", "imagePath": "https://imgproxy.kitesheet.com/ae6hPIyQ4529pu5oCMxtkaFU9Nx3cHctiScMnht_oVM/rs:fit:1200:1200:0/q:82/f:webp/czM6Ly9raXRlc2hlZXQvY29ycHVzL3NsaWRlcy84NWQwNmNiOWYyMzEvcDAwMS5wbmc", "rawType": "appendix_disclosure", "block": null, "metadata": { "slideType": "appendix_disclosure", "slideTypeCanon": { "name": "Appendix disclosure", "slug": "appendix_disclosure", "status": "active", "canonId": "019de52d-07b2-7549-8e8b-932a19f6e616", "version": 1, "description": null }, "function": "front_matter", "functionCanon": { "name": "Front matter", "slug": "front_matter", "status": "active", "canonId": "019de52d-133d-73f0-9e26-201eda96b098", "version": 1, "description": null }, "density": "dense", "densityScore": 61, "componentCount": 5, "textChars": 962, "nDataPoints": 0, "notes": "This is a regulatory filing document (Citizen Petition) formatted as a letter.", "elementsJson": [ "paragraph" ], "confidence": 1, "extraction": { "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "at": "2026-05-02 20:14:34.927+00", "seconds": 2.372, "promptVersion": "v2-canon-conditioned" } }, "links": { "slide": "/slides/019dd923-622c-750b-8b9a-36086e11ebef/1", "deck": "/decks/019dd923-622c-750b-8b9a-36086e11ebef", "deckAnchor": "/decks/019dd923-622c-750b-8b9a-36086e11ebef#slide-1", "deckJson": "/decks/019dd923-622c-750b-8b9a-36086e11ebef.json" }, "components": [ { "bbox": null, "kind": "callout", "text": "Petitioner is aware of three reports in recent weeks of young patients hospitalized for potential heart failure shortly after starting VYKAT XR. 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Monitor for signs or symptoms of edema or fluid overload.”", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "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 21:26:28.24+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "8cf669c0-c588-4e6c-bc72-5ba812f34a1f", "parentComponentId": null }, { "bbox": { "h": 0.07, "w": 0.78, "x": 0.11, "y": 0.09 }, "kind": "paragraph", "text": "Moreover, the use of a vague and unhelpful metric (“hundreds of start forms”) as the denominator versus the actual number of patients on drug is consistent with what Petitioner infers to be an ongoing pattern of obfuscation regarding the magnitude of VYKAT XR’s safety 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 21:26:28.24+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "9aa2ff31-0b57-4612-8d24-30fa05029047", "parentComponentId": null }, { "bbox": { "h": 0.07, "w": 0.78, "x": 0.11, "y": 0.16 }, "kind": "paragraph", "text": "One piece of new information provided by Soleno suggests that the denominator may be ~135 patients. The Guggenheim note states that “as of August 15, 2025, SLNO reported 5.2% AE-related discontinuations for commercial VYKAT XR 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 21:26:28.24+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "b39492dc-1d79-438e-ae04-0ee8a7d7c694", "parentComponentId": null }, { "bbox": { "h": 0.35, "w": 0.78, "x": 0.11, "y": 0.31 }, "kind": "paragraph", "text": "Report #1: On Jul 20, 2025, a parent posted in an online forum... Report #2: On July 28, 2025, a second parent replied... Report #3: On August 8, 2025, a third parent replied...", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "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 21:26:28.24+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "e49b60c9-b1da-4358-8fad-35f96c272c00", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "We have been in the hospital since Friday!!! Retained fluid all over especially his lungs with potential heart failure. Stopping Vykat aka diazoxide choline for good!!! — Parent report #1", "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 23:19:13+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-14dc-7419-88bf-d65de468b86f", "parentComponentId": null } ], "metrics": [], "tools": [], "frameworks": [ { "matchId": "6ae09fc1-2914-4269-8807-cd884950d422", "evidence": "The slide explicitly argues that the company is obfuscating safety data to hide a crisis.", "framework": null, "confidence": 0.85, "extraction": { "at": "2026-05-02 21:26:28.24+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "pageNumber": 3, "frameworkName": "fraud-exposure" } ], "arcBeats": [ { "to": 5, "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": "Problem & Complication", "beatId": "69f60f3b-27cc-471c-aa78-ba0d72634363", "matchId": "346c0a43-8a83-467d-8dae-fb1e23374cea", "beatType": { "name": "Problem & Complication", "slug": "consultants-gambit-problem-complication", "status": "active", "canonId": "019dd9b8-064a-777f-a374-e9a8c43dedd4", "version": 1, "description": null }, "evidence": "Slides expose contradictions and highlight significant concerns regarding Soleno’s publications.", "position": 0, "isPrimaryArc": true, "parentBeatType": { "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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Diazoxide's inherent toxicity is well-documented... 2. A critical finding... 3. The finding that diuretics are insufficient... 4. Critically, diazoxide-induced edema is not dose dependent.", "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 20:14:38.336+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "2e080ecb-3fe3-45f3-920a-018aee575fb5", "parentComponentId": null }, { "bbox": { "h": 0.15, "w": 0.78, "x": 0.11, "y": 0.09 }, "kind": "paragraph", "text": "The warning is woefully inadequate and is obviously failing to prevent hospitalizations. The literature is unequivocal that diazoxide mechanistically causes fluid retention.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "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 20:14:38.336+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "092b69bd-ce5a-4408-8a5a-2831f7a1c39f", "parentComponentId": null }, { "bbox": { "h": 0.15, "w": 0.78, "x": 0.11, "y": 0.25 }, "kind": "paragraph", "text": "In the absence of diuretics, the guidelines make it clear that diazoxide leads to uncontrolled fluid retention and PH; thus the addition of diuretics is standard of care.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "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 20:14:38.336+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "3942fe59-7d0c-4cd9-8346-fa135e95375b", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "\"The danger of diazoxide in the neonatal intensive care unit\" — Desai et al, 2021. \"...three of eight patients received diuretics throughout the period of time that they developed respiratory deterioration and fluid overload\"; 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The data also exhibits troubling irregularities, leading Petitioner to question the validity of the published safety information as well as the integrity of Soleno’s submissions to the FDA.", "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 20:14:36.182+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "d45d8295-305f-456e-a891-684c5b7ff7d9", "parentComponentId": null }, { "bbox": null, "kind": "callout", "text": "The data also exhibits troubling irregularities, leading Petitioner to question the validity of the published safety information as well as the integrity of Soleno’s submissions to the FDA.", "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 23:19:16+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-14dc-7419-88c0-f6c96d72252d", "parentComponentId": null }, { "bbox": { "h": 0.45, "w": 0.78, "x": 0.11, "y": 0.18 }, "kind": "list", "text": "5. Monitoring is ineffective... 6. Fluid retention tips into pulmonary crisis... 7. Parents are reporting concern... 8. Diuretics are far from benign... 9. VYKAT XR in conjunction with growth hormone...", "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 20:14:36.182+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "16c15a0a-3107-46bf-a110-36e0f9f7fb47", "parentComponentId": null }, { "bbox": { "h": 0.18, "w": 0.78, "x": 0.11, "y": 0.74 }, "kind": "list", "text": "1. Pulmonary edema, a serious adverse event, is buried... 2. Unusually, the edema adverse event data in the Prescribing Information and Medication Guide as part of the VYKAT XR FDA label do not match...", "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 20:14:36.182+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "ff4d32ad-0012-4011-b4ee-9bff0b86b9e9", "parentComponentId": null }, { "bbox": { "h": 0.08, "w": 0.78, "x": 0.11, "y": 0.09 }, "kind": "paragraph", "text": "We highlight this crucial point as Soleno appears to be 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“Per mgmt, SLNO is encouraging slower titration and a lower max dose in order to minimize titration-related AE exacerbation.” — Guggenheim note. “He too is severely overweight and so the side effects weren’t noticeable until it was too late.” — Report, p.25. “started with wheezing [sic] hard to breathe etc.” — Report #1. “then just boom” — Report #1. “The commonest adverse effect of GH replacement is fluid retention, which arises because of the anti-natriuretic action of GH.” — Ho et al (Journal of Endocrinology, 2023). “Growth Hormone and Fluid Retention”: “a major side effect of growth hormone (GH) administration is fluid retention.” — Moller et al (Hormone Research in Pediatrics, 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", 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VYKAT XR lacks evidence of efficacy; and even if it was efficacious, the labeled indication for hyperphagia/appetite reduction cannot justify hospitalization and heart failure risks.", "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 20:14:36.628+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "b730cea8-c841-4bae-a057-9c965eda3a71", "parentComponentId": null }, { "bbox": { "h": 0.15, "w": 0.78, "x": 0.11, "y": 0.12 }, "kind": "paragraph", "text": "3. The prevalence of edema appears to increase the longer that VYKAT XR is used, with no apparent plateau – indicating that a tipping point is eventually reached whether discontinuation or a safety event.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "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 20:14:36.628+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "51d8b604-a0de-4e61-b294-cae7fa6efc34", "parentComponentId": null }, { "bbox": { "h": 0.12, "w": 0.78, "x": 0.11, "y": 0.83 }, "kind": "paragraph", "text": "1. The pivotal phase 3 study did not show a statistically significant reduction in hyperphagia. We understand that the FDA was poised to reject approval as of that point, but relented after a petition campaign.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "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 20:14:36.628+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "8daec564-38ec-4d46-b3b7-3bcab20f5bab", "parentComponentId": null }, { "bbox": { "h": 0.12, "w": 0.78, "x": 0.11, "y": 0.28 }, "kind": "paragraph", "text": "4. Soleno obscures the alarming level of fluid retention by conflating it in its studies as an increase in lean body mass (LBM), by using DEXA scans to assess LBM.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "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 20:14:36.628+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "a2db8714-6f45-437e-8764-87d3302263aa", "parentComponentId": null }, { "bbox": { "h": 0.12, "w": 0.78, "x": 0.11, "y": 0.66 }, "kind": "paragraph", "text": "VYKAT XR is not a cure for PWS. It merely addresses one of numerous symptoms (hyperphagia) associated with a complex genetic 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 20:14:36.628+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "a59a15d2-4120-4fbb-8975-c34423b02039", "parentComponentId": null }, { "bbox": { "h": 0.15, "w": 0.78, "x": 0.11, "y": 0.41 }, "kind": "paragraph", "text": "5. We are troubled that Soleno assessed electrocardiogram (ECG) results during the P3 study but the paper buries the results with no mention of ECG.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "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 20:14:36.628+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "e4a6e822-0b2c-423c-a3e6-58a74375737e", "parentComponentId": null }, { "bbox": null, "kind": "quote", "text": "“whether it was manipulative or not...all people, to a degree, are trying to sell something...”; “I did feel like they were overemphasizing the horror stories...in my experience, my current patients don't have that...”; “they told a lot of horror stories...the amount of mailings and things I've got... 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Other arcs embed evidence inline within development." }, "alignedBlockIds": null, "matchConfidence": 0.8 } ], "loops": [], "locked": true }, { "page": 7, "type": "setup", "title": "This slide functions as a legal/regulatory petition document, outlining specific grievances regarding trial design, data integrity, and patient safety.", "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": "overcrowded", "densityScore": 83, "componentCount": 7, "textChars": 1171, "nDataPoints": 6, "notes": "This slide functions as a legal/regulatory petition document, outlining specific grievances regarding trial design, data integrity, and patient safety.", "elementsJson": [ "paragraph", "numbered_list" ], "confidence": 0.95, "extraction": { "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "at": "2026-05-02 20:14:36.77+00", "seconds": 3.215, "promptVersion": "v2-canon-conditioned" } }, "links": { "slide": "/slides/019dd923-622c-750b-8b9a-36086e11ebef/7", "deck": "/decks/019dd923-622c-750b-8b9a-36086e11ebef", "deckAnchor": "/decks/019dd923-622c-750b-8b9a-36086e11ebef#slide-7", "deckJson": "/decks/019dd923-622c-750b-8b9a-36086e11ebef.json" }, "components": [ { "bbox": null, "kind": "callout", "text": "This petition requests that the FDA take the following actions: 1. Request a voluntary recall of VYKAT XR from the US market, on the grounds that the drug presents a serious risk of adverse events, including hospitalization and potential heart failure, which outweigh its labeled indication.", "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 23:19:13+00", "model": "unknown-legacy", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "019dd953-14dc-7419-88bf-8959aafd6110", "parentComponentId": null }, { "bbox": { "h": 0.35, "w": 0.75, "x": 0.14, "y": 0.31 }, "kind": "list", "text": "a. No published manuscript. b. Small sample size (n=77) and site bias. c. Suspicious p-value (0.049) and data integrity concerns.", "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 20:14:36.77+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "d3cb47a4-c687-4459-b645-174ddbecf324", "parentComponentId": null }, { "bbox": { "h": 0.12, "w": 0.78, "x": 0.11, "y": 0.78 }, "kind": "list", "text": "1. Request a voluntary recall of VYKAT XR. 2. Issue a formal public health advisory.", "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 20:14:36.77+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "86f89a87-96b6-4e3c-90eb-7cb2f48b7d7a", "parentComponentId": null }, { "bbox": { "h": 0.15, "w": 0.78, "x": 0.11, "y": 0.09 }, "kind": "paragraph", "text": "2. We highlight that the phase 3 study had an extremely low bar, and thus its failure is even more telling. It was merely a 13-week study with a highly-subjective caregiver questionnaire (HQ-CT) as the primary endpoint.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "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 20:14:36.77+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "19b8e8f0-8e35-4752-9fcf-209d70a5ad9d", "parentComponentId": null }, { "bbox": { "h": 0.08, "w": 0.78, "x": 0.11, "y": 0.62 }, "kind": "paragraph", "text": "4. Real-world reports indicate that VYKAXT XR is actually increasing hyperphagia. Some parents are reporting the worst hunger and food-seeking behavior they have seen in their kids.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "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 20:14:36.77+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "88d683fb-64b3-41c8-a58b-7bebb030c289", "parentComponentId": null }, { "bbox": { "h": 0.08, "w": 0.78, "x": 0.11, "y": 0.23 }, "kind": "paragraph", "text": "3. The FDA yielded after the petition campaign and allowed Soleno to proceed with a highly unusual 16-week randomized withdrawal study. 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"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 20:14:38.115+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "0e59c078-7d41-45f1-8335-7d82cda091f1", "parentComponentId": null }, { "bbox": { "h": 0.04, "w": 0.8, "x": 0.1, "y": 0.71 }, "kind": "paragraph", "text": "Petitioner claims a categorical exclusion under 21 C.F.R. § 25.30 and § 25.31, as the relief requested in this Citizen Petition will have no environmental impact statement is not required.", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "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 20:14:38.115+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "547b2885-4d1a-47eb-8138-dcad4f8254a0", "parentComponentId": null }, { "bbox": { "h": 0.04, "w": 0.8, "x": 0.1, "y": 0.21 }, "kind": "paragraph", "text": "Second, 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." 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Take any additional regulatory or enforcement actions that FDA deems appropriate to ensure that patients are not exposed to unreasonable and avoidable risks from continued marketing of this 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 20:14:38.115+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "75dccb57-294b-466e-a30b-77df33eaad8c", "parentComponentId": null }, { "bbox": { "h": 0.25, "w": 0.8, "x": 0.1, "y": 0.42 }, "kind": "paragraph", "text": "Scorpion Capital LLC is an investment firm that specializes in investigative due diligence... Petitioner previously submitted a Citizen Petition on Apr 4, 2023... Petitioner submitted a Citizen Petition on January 14, 2025...", "attrs": null, "canon": { "kind": { "name": "Paragraph", "slug": "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 20:14:38.115+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "d58c8b17-b903-412e-9025-d9f930c1d6e9", "parentComponentId": null }, { "bbox": { "h": 0.07, "w": 0.8, "x": 0.1, "y": 0.14 }, "kind": "paragraph", "text": "We highlight two such additional actions which the FDA may deem appropriate, as possibilities for the agency's consideration. First, VYKAT XR could be transitioned to a compassionate use program in conjunction with a REMS protocol for current patients who may perceive a benefit, given the large placebo effect visible in the trials and as discussed in our 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 20:14:38.115+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "dcfa4050-9ac0-4bb3-87d5-3dade2a7e841", "parentComponentId": null }, { "bbox": { "h": 0.03, "w": 0.8, "x": 0.1, "y": 0.79 }, "kind": "paragraph", "text": "Pursuant 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 20:14:38.115+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "f112337f-e9d1-4178-9c60-2d04547b2dc9", "parentComponentId": null }, { "bbox": { "h": 0.02, "w": 0.2, "x": 0.1, "y": 0.77 }, "kind": "title", "text": "D. Economic Impact", "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 20:14:38.115+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "09a4264e-93b9-423e-a259-5a7507612180", "parentComponentId": null }, { "bbox": { "h": 0.02, "w": 0.2, "x": 0.1, "y": 0.69 }, "kind": "title", "text": "C. 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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 20:14:39.986+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "2b75b696-5f10-4147-a416-8fb7f5ec254d", "parentComponentId": null } ], "metrics": [], "tools": [], "frameworks": [], "arcBeats": [], "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": 156, "nDataPoints": 0, "notes": null, "elementsJson": [ "paragraph" ], "confidence": 1, "extraction": { "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "at": "2026-05-02 20:14:37.451+00", "seconds": 3.149, "promptVersion": "v2-canon-conditioned" } }, "links": { "slide": "/slides/019dd923-622c-750b-8b9a-36086e11ebef/10", "deck": "/decks/019dd923-622c-750b-8b9a-36086e11ebef", "deckAnchor": "/decks/019dd923-622c-750b-8b9a-36086e11ebef#slide-10", "deckJson": "/decks/019dd923-622c-750b-8b9a-36086e11ebef.json" }, "components": [ { "bbox": { "h": 0.018, "w": 0.435, "x": 0.118, "y": 0.15 }, "kind": "paragraph", "text": "https://scorpionreports.s3.us-east-2.amazonaws.com/SLNO1.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 20:14:37.451+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "1b6941ab-7b66-4e51-af6c-b1371202c908", "parentComponentId": null }, { "bbox": { "h": 0.018, "w": 0.535, "x": 0.118, "y": 0.121 }, "kind": "paragraph", "text": "Petitioner's investigative report dated August 15, 2025. 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 20:14:37.451+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "807e4450-2c84-4277-ab21-86b2a2a65b98", "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 20:14:37.451+00", "model": "google/gemini-3.1-flash-lite-preview-20260303", "runId": null, "seconds": null, "promptVersion": null }, "componentId": "64608dd5-8e4c-4935-a47e-95829036c16c", "parentComponentId": null } ], "metrics": [], "tools": [], "frameworks": [], "arcBeats": [], "loops": [], "locked": true } ], "arcBeats": [ { "from": 2, "to": 5, "label": "Problem & Complication", "description": "Slides expose contradictions and highlight significant concerns regarding Soleno’s publications." }, { "from": 7, "to": 8, "label": "Solution & Approach", "description": "Slides request action and propose regulatory or enforcement actions." }, { "from": 1, "to": 1, "label": "Attention", "description": "The document begins with disclosures and attention-grabbing information." }, { "from": 6, "to": 6, "label": "Desire", "description": "The risk/reward imbalance creates a desire for change." }, { "from": 4, "to": 4, "label": "Need", "description": "The warning is noted to be inadequate, highlighting a need for action." } ], "loops": [] }