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  "documentTitle": "Soleno Therapeutics (SLNO)",
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  "authorName": "Scorpion Capital",
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  "presentationDate": "2025-08-15 00:00:00",
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  "notes": "The slide uses a Q&A format to highlight internal concerns regarding trial integrity and the potential for participant bias due to unblinding.",
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      "text": "The ex-employee indicated that the smell of the Vykat table versus placebo unblinded the trial and allowed parents to game the trial; and that individuals inside Soleno were concerned about the impact on HQ-CT hyperphagia scores",
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      "text": "Q: \"I noticed that if you look at the changes in the HQ-CT score in the randomized withdrawal period, the scores change right around when you would expect the side effects to reverse. Both in the Phase 3 and in the randomized withdrawal phase. I've seen this in trials that use a soft questionnaire PRO endpoint. Just a little bit of unblinding is enough. All these parents are very savvy. They want their kid on the drug and are trying to deduce if they're on the drug or the placebo. And if they infer correctly, incorrectly, that they're on one or the other, it dramatically affects their score on these surveys.\"\nA: \"You raise a very good point. It's something that many of us who were working on the trial raised and felt was valid.\" – Ex-Soleno employee #1, key role in clinical trial program",
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      "text": "Internal concern at Soleno re unblinding affecting HQ-CT scores",
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      "text": "Q: \"Was there any unblinding issue from DCCR having a different smell? Was that parents just imagining it?\"\nA: \"No, that's true.\"\nQ: \"DCCR does have a noticeably different smell than placebo?\"\nA: \"Yes. At least in the Phase 3 trial, it did have a different smell. Maybe they modified the formulation of the placebo to include another unpleasant smell so that it was masked for the next final trial.\"\nQ: \"Wow. What did it smell like? Or it's just too hard to say?\"\nA: \"It's hard to say, but if you are smelling it, you could tell the difference between active and placebo.\"\nQ: \"I mean, that just completely undermines the trial.\"\nA: \"Well...the thing with orphan diseases, the parents are chit-chatting in their WhatsApp group, chat group, and then the community is very tight. They discuss a lot like, is your kid on active or placebo? How do I get my kid on active? They all want to game the system to get on the active drug because they're desperate.\" – Ex-Soleno employee #1, key role in clinical trial program",
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      "text": "Vykat had different small than placebo; families figured it out",
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      "text": "“You raise a very good point. It’s something that many of us who were working on the trial raised and felt was valid.” — Ex-Soleno employee #1, key role in clinical trial program; “Well...the thing with orphan diseases, the parents are chit-chatting in their WhatsApp group, chat group, and then the community is very tight. They discuss a lot like, is your kid on active or placebo? How do I get my kid on active? They all want to game the system to get on the active drug because they’re desperate.” — Ex-Soleno employee #1, key role in clinical trial program",
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      "text": "Source: Scorpion Capital consultation calls with experts",
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