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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": "The slide is a text-heavy regulatory filing page, likely part of a petition or formal complaint. It uses numbered points to build a case of scientific misconduct.",
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      "text": "Petitioner has significant concerns regarding the manner in which Soleno’s publications appear to repeatedly obscure and downplay the severe risk of fluid retention. The data also exhibits troubling irregularities, leading Petitioner to question the validity of the published safety information as well as the integrity of Soleno’s submissions to the FDA.",
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      "text": "The data also exhibits troubling irregularities, leading Petitioner to question the validity of the published safety information as well as the integrity of Soleno’s submissions to the FDA.",
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      "text": "5. Monitoring is ineffective... 6. Fluid retention tips into pulmonary crisis... 7. Parents are reporting concern... 8. Diuretics are far from benign... 9. VYKAT XR in conjunction with growth hormone...",
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      "text": "1. Pulmonary edema, a serious adverse event, is buried... 2. Unusually, the edema adverse event data in the Prescribing Information and Medication Guide as part of the VYKAT XR FDA label do not match...",
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      "kind": "paragraph",
      "text": "We highlight this crucial point as Soleno appears to be downplaying and deflecting the adverse events as due to titration-related issues...",
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      "kind": "quote",
      "text": "“Mgmt speculated that some SAEs may have occurred in patients that have not been titrated adequately onto the drug” — Guggenheim note. “Per mgmt, SLNO is encouraging slower titration and a lower max dose in order to minimize titration-related AE exacerbation.” — Guggenheim note. “He too is severely overweight and so the side effects weren’t noticeable until it was too late.” — Report, p.25. “started with wheezing [sic] hard to breathe etc.” — Report #1. “then just boom” — Report #1. “The commonest adverse effect of GH replacement is fluid retention, which arises because of the anti-natriuretic action of GH.” — Ho et al (Journal of Endocrinology, 2023). “Growth Hormone and Fluid Retention”: “a major side effect of growth hormone (GH) administration is fluid retention.” — Moller et al (Hormone Research in Pediatrics, 2004).",
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