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  "documentTitle": "Soleno Therapeutics (SLNO)",
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  "presentationDate": "2025-08-15 00:00:00",
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  "notes": "The slide uses a screenshot of an FDA Medication Guide to contrast with the claim that DKA is missing from clinical literature.",
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      "kind": "callout",
      "text": "diabetic ketoacidosis\n- nausea\n- vomiting\n- stomach-area (abdominal) pain\n- feel weak or very tired\n- trouble breathing",
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      "text": "The prominent placement of diabetic ketoacidosis in the Medication Guide in the FDA label is telling.",
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      "text": "Both are life-threatening complications. DKA involves a severe lack of insulin, leading to high blood sugar and the buildup of ketones. Given that diazoxide suppresses insulin by >50%, DKA is a mechanistically-inherent extreme risk of DCCR therapy. The FDA label mentions diabetic ketoacidosis 8 times - “one subject in Study 3 experienced a serious adverse reaction of diabetic ketoacidosis” - yet we see no mention or discussion of DKA in the phase 3 or open-label manuscripts. DKA always requires hospitalization, yet the only hospitalizations referenced in the OLE study (“study 3” in the label) are vague with no indication of DKA. The prominent placement of diabetic ketoacidosis in the Medication Guide in the FDA label is telling.",
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      "text": "one subject in Study 3 experienced a serious adverse reaction of diabetic ketoacidosis — FDA label",
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      "text": "Source: https://pmc.ncbi.nlm.nih.gov/articles/PMC12181816/pdf/nihms-2090141.pdf",
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      "text": "Soleno also buries the risk of diabetic ketoacidosis (DKA), which requires hospitalization and can present with hyperosmolar hyperglycemia state (HHS).",
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