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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 argument, using evidence-based reasoning to refute the adequacy of current safety warnings.",
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      "text": "Petitioner sees no option except recalling VYKAT XR from market - without diuretics patients are at risk of fluid retention and PH, but there is no safety data or study to justify placing PWS patients on this combo.",
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      "text": "1. Diazoxide's inherent toxicity is well-documented... 2. A critical finding... 3. The finding that diuretics are insufficient... 4. Critically, diazoxide-induced edema is not dose dependent.",
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      "text": "The warning is woefully inadequate and is obviously failing to prevent hospitalizations. The literature is unequivocal that diazoxide mechanistically causes fluid retention.",
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      "text": "In the absence of diuretics, the guidelines make it clear that diazoxide leads to uncontrolled fluid retention and PH; thus the addition of diuretics is standard of care.",
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      "kind": "quote",
      "text": "\"The danger of diazoxide in the neonatal intensive care unit\" — Desai et al, 2021. \"...three of eight patients received diuretics throughout the period of time that they developed respiratory deterioration and fluid overload\"; \"however, they did not show any signs of improvement until the diazoxide was discontinued.\" — Desai et al, 2021. \"been working a month now to get the fluid off with Lasix and pt.\" — Report #3. \"Development of Pulmonary Hypertension During Treatment with Diazoxide: A Case Series and Literature Review\" — Timlin et al, 2017.",
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