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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 appears to be a page from a regulatory filing or activist short report, focusing on adverse event reporting and potential obfuscation by the manufacturer.",
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      "kind": "callout",
      "text": "Remedial measures such as diuretics, monitoring, slower titration, or label changes are unlikely to mitigate the emerging safety crisis.",
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      "text": "Details regarding 3 reports of potential heart failure in recent weeks:",
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      "kind": "paragraph",
      "text": "In addition, Petitioner is observing numerous online reports of parents indicating symptoms consistent with potential creeping fluid retention, potential pulmonary edema, and diabetic ketoacidosis.",
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      "text": "The labeled warnings and precautions section states “Risk of Fluid Overload: Edema, including severe reactions associated with fluid overload, has been reported. Monitor for signs or symptoms of edema or fluid overload.”",
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      "text": "Moreover, the use of a vague and unhelpful metric (“hundreds of start forms”) as the denominator versus the actual number of patients on drug is consistent with what Petitioner infers to be an ongoing pattern of obfuscation regarding the magnitude of VYKAT XR’s safety signal.",
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      "text": "One piece of new information provided by Soleno suggests that the denominator may be ~135 patients. The Guggenheim note states that “as of August 15, 2025, SLNO reported 5.2% AE-related discontinuations for commercial VYKAT XR patients.”",
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      "kind": "paragraph",
      "text": "Report #1: On Jul 20, 2025, a parent posted in an online forum... Report #2: On July 28, 2025, a second parent replied... Report #3: On August 8, 2025, a third parent replied...",
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      "kind": "quote",
      "text": "We have been in the hospital since Friday!!! Retained fluid all over especially his lungs with potential heart failure. Stopping Vykat aka diazoxide choline for good!!! — Parent report #1",
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