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  "documentTitle": "Soleno Therapeutics (SLNO)",
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  "notes": "This appears to be a page from an activist short report or regulatory challenge document.",
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      "kind": "callout",
      "text": "Risk/reward imbalance warrants immediate market withdrawal. 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.",
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      "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.",
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      "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.",
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      "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.",
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      "text": "VYKAT XR is not a cure for PWS. It merely addresses one of numerous symptoms (hyperphagia) associated with a complex genetic condition.",
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      "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.",
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      "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... I don't remember the last time I got this much...” — Endocrinologists",
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