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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 direct quotes from a trial investigator to undermine the drug's efficacy and safety profile.",
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      "text": "Indicated the drug has no benefit in hyperphagia as it still requires restrictive food security measures, defeating its purpose: \"not going to be helpful at all to the families who don't have the ability to control the environment.\"",
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      "text": "Admitted that the trials were basically unblinded because the side effects were obvious - “she got hairy...so I was pretty sure she on real drug...”; “there certainly was potential for unblinding...no question.”",
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      "text": "Noted significant adverse effects like edema, hyperglycemia, and hairiness, stating that Vykat raised patients’ fasting glucose levels and caused concern about a diabetes safety signal: “I’ll probably be quite cautious in the population that’s already got blood glucose intolerance.”",
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      "text": "Even more telling, the investigator elaborated upon a Vykat patient who “probably put on 50 pounds during the 13-week C-601 [pivotal phase 3] trial and then rolled over [to open label] and continued to put on weight...the family withdrew her in order to hospitalize her” due to the uncontrolled weight gain.",
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      "text": "Stated that the Vykat tablet was too large for some patients and that they had to use several of the smaller dose tablets instead; and indicated they even tried to exclude patients who couldn’t swallow a tablet - “in order to get in the study, you had to be able to demonstrate that you could swallow a pill” - “some folks couldn’t swallow that big a pill, so we had to use the 75 mg for them instead...so yeah, the 150 mg is a big pill.”",
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      "text": "Indicated the drug has no benefit in hyperphagia as it still requires restrictive food security measures, defeating its purpose: “not going to be helpful at all to the families who don’t have the ability to control the environment.”",
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      "text": "Given the self-evident danger of a “horse pill” in PWS patients with impaired swallowing and high risk of choking, we asked why physicians wouldn’t just use generic diazoxide suspension instead: “no, I don’t think you’re missing anything...just out of the goodness of my heat, maybe I’ll end up prescribing plain old diazoxide...I guess we’ll see in a little while, because there’ll be plenty of people who will be doing it”; “everybody can take that, whereas not everybody can swallow a pill.”",
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      "text": "\"not going to be helpful at all to the families who don't have the ability to control the environment.\" — Trial investigator #5; \"probably put on 50 pounds during the 13-week C-601 [pivotal phase 3] trial and then rolled over [to open label] and continued to put on weight...the family withdrew her in order to hospitalize her\" — Trial investigator #5; \"she got hairy...so I was pretty sure she on real drug...\"; \"there certainly was potential for unblinding...no question.\" — Trial investigator #5; \"I'll probably be quite cautious in the population that's already got blood glucose intolerance.\" — Trial investigator #5; \"in order to get in the study, you had to be able to demonstrate that you could swallow a pill\" — \"some folks couldn't swallow that big a pill, so we had to use the 75 mg for them instead...so yeah, the 150 mg is a big pill.\" — Trial investigator #5; \"no, I don't think you're missing anything...just out of the goodness of my heat, maybe I'll end up prescribing plain old diazoxide...I guess we'll see in a little while, because there'll be plenty of people who will be doing it\"; \"everybody can take that, whereas not everybody can swallow a pill.\" — Trial investigator #5",
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      "text": "Source: Scorpion Capital consultation calls with experts",
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      "text": "Trial investigator #5 (cont'd): Influential key opinion leader with >40 PWS patients currently.",
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