{ "docId": "019dd923-622c-750b-8b9a-36086e11ebef", "docSlug": "85d06cb9f231", "documentTitle": "Soleno Therapeutics (SLNO)", "authorId": "58_Scorpion_Capital", "authorName": "Kir Kahlon", "documentKindSlug": "regulatory-filing", "documentKindLabel": "Regulatory filing", "sourceTypeSlug": "short_seller", "sourceTypeLabel": "Short seller", "presentationDate": "2025-08-21 00:00:00", "orientation": "portrait", "aspectRatio": 0.77272725, "pageNumber": 8, "pageCount": 10, "prevPage": 7, "nextPage": 9, "slideType": "regulatory-filing", "function": "state_demand", "density": "overcrowded", "nDataPoints": 0, "notes": "This is a text-heavy regulatory document page.", "elementsJson": [ "paragraph" ], "metadataConfidence": 1, "imagePath": null, "slideHref": "/slides/019dd923-622c-750b-8b9a-36086e11ebef/8", "deckHref": "/decks/019dd923-622c-750b-8b9a-36086e11ebef", "deckJsonHref": "/decks/019dd923-622c-750b-8b9a-36086e11ebef.json", "deckAnchorHref": "/decks/019dd923-622c-750b-8b9a-36086e11ebef#slide-8", "components": [ { "bbox": null, "kind": "callout", "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, "subkind": null, "toolName": "Visual emphasis", "toolSlug": "visual-emphasis", "confidence": null, "componentId": "019dd953-14dc-7419-88c0-bdb50c291067", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.05, "w": 0.8, "x": 0.1, "y": 0.33 }, "kind": "paragraph", "text": "In addition to all of the information detailed supra, and incorporated by reference, Petitioner has enclosed with this Citizen Petition (and incorporates herein) a 415-page investigative report and provides it as its statement of grounds (Exhibit A).", "attrs": null, "subkind": "paragraph", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "0e59c078-7d41-45f1-8335-7d82cda091f1", "frameworkName": null, "frameworkSlug": 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, "subkind": "paragraph", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "547b2885-4d1a-47eb-8138-dcad4f8254a0", "frameworkName": null, "frameworkSlug": 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, "subkind": "paragraph", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "71ad2935-b83e-4173-bea6-c8e426d2ca68", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.05, "w": 0.8, "x": 0.1, "y": 0.09 }, "kind": "paragraph", "text": "3. 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, "subkind": "paragraph", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "75dccb57-294b-466e-a30b-77df33eaad8c", "frameworkName": null, "frameworkSlug": 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, "subkind": "paragraph", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "d58c8b17-b903-412e-9025-d9f930c1d6e9", "frameworkName": null, "frameworkSlug": 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, "subkind": "paragraph", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "dcfa4050-9ac0-4bb3-87d5-3dade2a7e841", "frameworkName": null, "frameworkSlug": 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, "subkind": "paragraph", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "f112337f-e9d1-4178-9c60-2d04547b2dc9", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.02, "w": 0.2, "x": 0.1, "y": 0.77 }, "kind": "title", "text": "D. 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