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  "documentTitle": "Soleno Therapeutics (SLNO)",
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      "text": "A: “There were three main side effects which not everybody gets. I want to say about 15% may have had the side effect of edema and maybe 20% the side effect of hyperglycemia and maybe 20% the side effect of hypertrichosis. There certainly was potential for unblinding. No question..\"",
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      "text": "A: “It does. It does. If you are waiting to use it until the patients are already massively obese and diabetic.,,my own personal experience was that...the folks who did have glucose elevations, it just bumped up their fasting glucose by five or ten points, but it didn't tip them over into diabetes. Now, again, I have a small n, but my sense is that it sort of reset your fasting blood sugar up ten points. That was my observation.”",
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      "text": "A: “I’ll probably be quite cautious in the population that’s already got blood glucose intolerance. Probably would monitor them really closely if I started this drug.” -Trial investigator, pediatrician/geneticist, professor",
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      "text": "There certainly was potential for unblinding...no question.",
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      "text": "Q: “What do you think about the diabetes issue? When I looked at the data for the pilot study, it looked like there were 13 patients. One got full-blown diabetes. A number of others appear to become pre-diabetic. It was artfully worded in the adverse events table. And I've seen different figures that maybe up to 40% of the PWS population is diabetic. Does that limit the commercial opportunity and applicability?”",
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      "text": "Cautious about diabetes risk; limits TAM; resets fasting glucose by 10 points per investigators personal observations",
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      "text": "Q: “The adverse events table says...20% have hypotrichosis? Even if it's 20%, that level of unblinding is enough to make the p-value completely unreliable.”",
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      "text": "Trial was essentially unblinded major adverse events like edema, hairiness, hyperglycemia",
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      "text": "Q: “Are you worried about risk of any kind of safety signal emerging?”",
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      "text": "A: “Yeah, 20% would be enough to, yeah.” -Trial investigator, pediatrician/geneticist, professor",
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      "text": "“There were three main side effects which not everybody gets. I want to say about 15% may have had the side effect of edema and maybe 20% the side effect of hyperglycemia and maybe 20% the side effect of hypertrichosis. There certainly was potential for unblinding. No question..” — Trial investigator, pediatrician/geneticist, professor",
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      "text": "Source: Scorpion Capital consultation calls with experts",
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      "text": "Trial investigator #5 noted significant adverse effects like edema, hyperglycemia, and hairiness – which while troubling also undermined the entire trials as they were so visibly related to Vykat: “there certainly was potential for unblinding…no question.” The investigator indicated 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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