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  "documentTitle": "Soleno Therapeutics (SLNO)",
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  "notes": "The slide highlights a discrepancy between the FDA label's explicit warnings about DKA and the company's omission of this risk in their phase 3 and open-label manuscripts.",
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      "text": "Given that diazoxide suppresses insulin by >50%, DKA is a mechanistically-inherent extreme risk.",
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      "text": "nausea, vomiting, stomach-area (abdominal) pain, feel weak or very tired, trouble breathing",
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      "text": "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.",
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      "text": "DKA always requires hospitalization, yet the only hospitalizations we see 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": "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.",
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