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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 'villain' or 'expert critic' framing to undermine the credibility of a clinical trial and its associated drug.",
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      "text": "Highly skeptical of the phase 3 trial and especially the “unusual” withdrawal study that was the basis of FDA approval, stating the data was unreliable; that he didn’t see a change in his patients.",
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      "text": "Highly critical of the HQ-CT endpoint, blasting it as soft and subjective unlike histologic markers; indicated the baseline HQ-CT scores made no sense, and questioned if the statistical artifacts in the trial were just elevated baseline scores falling to the average level in PWS patients due to placebo – “the HQ-CT score, it’s not a great marker...it’s a subjective core...will vary depending on...whether it’s the mom, dad, or grandparents”; “the median score of 20, that’s a very high score...most of my patients are nowhere near that...is it just placebo effect goes down for the score from 23 down to 15...is that really the drug?”",
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      "text": "Stated that the vast majority of PWS are simply not candidates for Vykat: patients under 10 are easily managed by parents who can keep hyperphagia under control; and of the older patients, 30-40% are diabetic and inappropriate for the drug. He added that the PWS patients who need a drug the most are the ones with the least compliance and food security measures, making any drug ineffective.",
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      "text": "Highly skeptical of the phase 3 trial and especially the “unusual” withdrawal study that was the basis of FDA approval, stating the data was unreliable; that he didn’t see a change in his patients; that confounding factors made the hyperphagia questionnaire scores dubious; that the trial had a “strong placebo effect”; and that the HQ-CT instrument was flawed due to inflated baseline scores, subjectivity, and was not a “true genuine score” – “there was not a huge difference in my patients...so really, what was the improvement?”; “all these drugs have a strong placebo effect...you could argue that it was placebo effect”; “placebo withdrawal which is unusual in terms of trials...an unusual study plan...that’s unusual.”",
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      "text": "Indicated tepid interest in the field toward Vykat and that the TAM is “at most” 10% of PWS patients, with possibly 10-15% of patients who may “trial it” over the next two to five years.",
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      "text": "“there was not a huge difference in my patients...so really, what was the improvement?”; “all these drugs have a strong placebo effect...you could argue that it was placebo effect”; “placebo withdrawal which is unusual in terms of trials...an unusual study plan...that’s unusual.”; “the HQ-CT score, it’s not a great marker...it’s a subjective core...will vary depending on...whether it’s the mom, dad, or grandparents”; “the median score of 20, that’s a very high score...most of my patients are nowhere near that...is it just placebo effect goes down for the score from 23 down to 15...is that really the drug?” — Trial investigator #7",
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      "text": "Source: Scorpion Capital consultation calls with experts",
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      "text": "Trial investigator #7: Co-author on Soleno trial paper and a key opinion leader with ~40 PWS patients at one of the largest clinics; developed the PWS treatment guidelines. Participated in the phase 3, open-label, and withdrawal studies.",
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