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  "documentTitle": "Soleno Therapeutics (SLNO)",
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  "authorName": "Scorpion Capital",
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  "notes": "The slide uses a process diagram to illustrate the clinical trial flow, highlighting the transition from the failed C601 trial to the C602 withdrawal study.",
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      "text": "The trial was a failure as DCCR did not significantly improve HQ-CT scores.",
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      "text": "Soleno’s clinical trials were a sham that make a mockery of the scientific method. DESTINY PWS (C601) was a 13-week double-blind placebo-controlled phase 3 trial with 127 participants with PWS aged 4 years and older. The primary endpoint was change in hyperphagia using the Hyperphagia Questionnaire for Clinical Trials (HQ-CT). The trial was a failure as DCCR did not significantly improve HQ-CT scores. A post-hoc analysis was then used to claim HQ-CT benefit in a sub-group of patients with severe baseline hyperphagia. We understand that the FDA was inclined to reject approval at that point. A high-pressure petition campaign was organized by a PWS association. The FDA allowed Soleno to proceed with an unusual 16-week randomized withdrawal study (C602-RWP) which is the pivotal.",
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