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  "documentTitle": "Soleno Therapeutics (SLNO)",
  "authorId": "58_Scorpion_Capital",
  "authorName": "Scorpion Capital",
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  "sourceTypeLabel": "Short seller",
  "presentationDate": "2025-08-15 00:00:00",
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  "notes": "Uses FDA label excerpts to highlight the contradiction between the drug's design and its actual usage/safety profile.",
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      "text": "Moreover, chewing turns Soleno’s only argument about Vykat’s purported PK superiority on its head, since it releases the entire dose at once, and thus the CEO shoots himself with his own arrow by claiming that “high levels...put the person at significant risk.”",
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      "text": "2.2 Dosage and Administration Recommendations\nAdminister VYKAT XR orally with or without food once daily [see Clinical Pharmacology (12.3)].\nSwallow tablets whole. Do not split, crush, or chew the extended-release tablets because doing so may compromise the extended-release characteristics, efficacy, or safety of VYKAT XR.\n17 PATIENT COUNSELING INFORMATION\nAdvise the patient to read the FDA-approved patient labeling (Medication Guide).\nAdministration Instructions\nAdvise patients to swallow tablets whole and not to split, crush, or chew VYKAT XR [see Dosage and Administration (2.2)].\nHow should I take VYKAT XR?\n• Take VYKAT XR exactly as your healthcare provider tells you to take it. Your healthcare provider will decide how much VYKAT XR you will take and may slowly increase your dose when you first start taking VYKAT XR.\n• Take VYKAT XR by mouth 1 time per day with or without food.\n• Swallow VYKAT XR tablets whole. Do not split, crush, or chew the tablets.",
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      "text": "In addition to zero pharmacokinetic, clinical, or dosing benefit, Vykat’s tablet formulation is reckless and dangerous versus oral suspension: prescribing tablets to children 4 and up per the label defies common sense, as liquids are the standard of care in pediatrics; choking/aspiration is the third-leading cause of death in PWS patients; numerous investigators told us kids had difficulty swallowing the tablet and were chewing it instead, which is contraindicated in the label and defeats the purpose of an extended-release tablet. Moreover, chewing turns Soleno’s only argument about Vykat’s purported PK superiority on its head, since it releases the entire dose at once, and thus the CEO shoots himself with his own arrow by claiming that “high levels...put the person at significant risk.” The FDA label warns three different times against chewing or cutting the tablets.",
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      "text": "“high levels...put the person at significant risk.” — Soleno CEO",
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      "text": "Source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/216665s000lbl.pdf",
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