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  "documentTitle": "Soleno Therapeutics (SLNO)",
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      "text": "Thus, the flimsy foundation upon which VYKAT’s efficacy rests is a worsening of hyperphagia, as assessed by HQ-CT scores, in the placebo group over 16 weeks.",
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      "text": "HQ-CT Total Score: 7.6",
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      "text": "It was the basis of approval. The label indicates that C602-RWP was the pivotal. The Clinical Studies section of the label omits mention of the DESTINY PWS phase 3 and includes only the HQ-CT score changes from RWP. Thus, the flimsy foundation upon which VYKAT’s efficacy rests is a worsening of hyperphagia, as assessed by HQ-CT scores, in the placebo group over 16 weeks.",
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      "text": "Table 5: Study 2-RWP HQ-CT Total Score, Least Square Mean Change from Baseline to the End of the Randomized Withdrawal Period (Week 16) in Patients with Hyperphagia and PWS",
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      "text": "The FDA then allowed Soleno to proceed with a small, highly unusual 16-week randomized withdrawal study.",
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