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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 an ex-employee to undermine the credibility of the company's clinical trial results.",
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      "kind": "callout",
      "text": "“No validated biomarkers”; obvious markers like PP and PYY allegedly not collected; Soleno bet on DEXA data which was “not really significant” and a problematic method to begin with",
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      "text": "HQ-CT is a poor endpoint that “doesn’t really reflect the behaviors” of PWS patients",
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      "text": "HQ-CT is a poor endpoint that “doesn’t really reflect the behaviors” of PWS patients",
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      "text": "The ex-employee blasted the clinical trials in their entirety for using an inaccurate, subjective, low-quality endpoint; for lacking “validated biomarkers”; for allegedly failing to collect obvious biomarkers like PP and PYY; and for relying on shoddy, inaccurate DEXA scans for body fat percentage – “anyone in the space will say, [HQ-CT] is a very subjective and difficult endpoint...doesn’t really reflect the behaviors of the Prader-Willi patient”; “no clear biomarker objective measure for any of the key symptoms, whether it’s hyperphagia or whatever; PP and PYY “was not collected”; and “challenges with collection” of DEXA data – “it just was not really significant...I have a number of concerns around the validity and value of DEXA data...”",
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      "text": "“I think there are challenges with the HQ-CT as a primary endpoint. Anyone in the space will say, it’s a very subjective and difficult endpoint to achieve. And a lot of people in that space would say, the HQ-CT probably doesn’t really reflect the behaviors of the Prader-Willi patient because of early diagnosis, intervention, and just a lot of regulation around food and behaviors around food. – Ex-Soleno employee #2, key role in clinical trial program",
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      "text": "A: “The problem is there are no validated biomarkers. There’s no clear biomarker objective measure for any of the key symptoms, whether it’s hyperphagia or whatever. I think that’s the real —”\nQ: “Well, there actually is one: PP and PYY. Do you know for a fact if they collected that data?”\nA: “It was not collected.”\nQ: “That’s one of the most obvious biomarkers to capture for a trial like this. What did you make of the fact that that was not included?”\nA: “I think they expected to see really promising results on DEXA. They were really banking on that. Looking at body fat relative to lean muscle mass and changes over time.”\nQ: “And what happened with the DEXA data? It sounded like you weren’t enthusiastic about it.”\nA: “There were some challenges with collection, too, because this trial was wrapping up around Covid. There was missing data that just was not collected because patients couldn’t get in to get the test done. And then it just was not really significant. There’s also challenges with using DEXA and body fat percentage in the pediatric population. I have a number of concerns around the validity and value of DEXA data, not only in this type of trial, but just in general in assessing.” - Ex-Soleno employee #2, key role in clinical trial program",
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      "text": "I think there are challenges with the HQ-CT as a primary endpoint. Anyone in the space will say, it's a very subjective and difficult endpoint to achieve. And a lot of people in that space would say, the HQ-CT probably doesn't really reflect the behaviors of the Prader-Willi patient because of early diagnosis, intervention, and just a lot of regulation around food and behaviors around food. — Ex-Soleno employee #2, key role in clinical trial program",
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      "text": "Source: Scorpion Capital consultation calls with experts",
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