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  "documentTitle": "Soleno Therapeutics (SLNO)",
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  "authorName": "Kir Kahlon",
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  "presentationDate": "2025-08-21 00:00:00",
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  "notes": "This slide functions as a legal/regulatory petition document, outlining specific grievances regarding trial design, data integrity, and patient safety.",
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      "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.",
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      "text": "a. No published manuscript. b. Small sample size (n=77) and site bias. c. Suspicious p-value (0.049) and data integrity concerns.",
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      "text": "1. Request a voluntary recall of VYKAT XR. 2. Issue a formal public health advisory.",
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      "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.",
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      "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.",
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      "text": "3. The FDA yielded after the petition campaign and allowed Soleno to proceed with a highly unusual 16-week randomized withdrawal study. A quick glance at the purported results is sufficient to infer that it makes a mockery of the scientific method.",
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