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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 KOL to undermine the credibility of the clinical trial results.",
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      "text": "Withdrawal study HQ-CT score change were not meaningful; red flag that key info is missing in the label",
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      "text": "Hyperphagia score reduction in HQ-CT survey is not compelling",
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      "text": "The KOL was skeptical of the randomized withdrawal study as well, noting that hyperphagia scores actually worsened in the drug arm",
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      "text": "“Investigators may have something to do with that Oh, I see your kid is like, oh my God, maybe they are. As an investigator, you can do a lot to move the needle, even if it’s not real movement...the data that is on their label is not nearly as compelling...so I’m just not entirely sure what to make of it. It’s got a modest effect on hyperphagia, which is better than nothing, but it’s not gigantic. And the FDA in the past has required eight points on the hyperphagia questionnaire to be considered clinically significant and meaningful data. Theirs isn’t there yet. It’s about five points difference between people on placebo and people on drugs. To me, that’s not a giant signal when I know the scale and it goes up to 36.” – KOL in the PWS field; involved with Soleno’s clinical program",
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      "text": "The KOL disputed both the failed phase 3 and the withdrawal study that was the basis of FDA approval, as the HQ-CT scores were easily manipulated – “as an investigator, you can do a lot to move the needle, even if it’s not real movement\" - and stated the 5-point HQ-CT reductions vs. placebo were meaningless on a 36-point scale vs. and questioned the FDA’s approval given past requirements – “the FDA in the past has required eight points on the hyperphagia questionnaire to be considered clinical significant and meaningful...theirs isn’t...not a giant signal.” The KOL was skeptical of the randomized withdrawal study as well, noting that hyperphagia scores actually worsened in the drug arm – “people who were on drug went up, I think, 2.6 points, which seems odd....people on placebo went up 7.8...about a five-point difference...in the original study [5 points] wasn’t statistically significant.”",
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      "text": "Q: “When you say it was a five-point change in the HQ-CT score, are you talking about the phase 3 subgroup analysis or overall result?” A: “Well, the overall results aren’t anywhere you can find. Like I looked at the label. I spent several hours going through the labeling information, so everything we know about the drug. The Vykat group, the only information that’s in labeling is the people who were in the randomized withdrawal part of the study: 38 were on drugs, 39 were switched to placebo during that time. Those changes over, I think, it’s four months, people who were on drug went up to, I think, it said 2.6 points, which seems odd. And people on placebo went up 7.6. It’s about a five-point difference between the two groups on people in that randomized withdrawal. In the original study, it wasn’t statistically significant, the change between placebo and people on drug, which I guess is why they’re not using label. I think that what people don’t say sometimes, is just as interesting as what people do say...” – KOL in the PWS field; involved with Soleno’s clinical program",
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      "text": "As an investigator, you can do a lot to move the needle, even if it’s not real movement...the FDA in the past has required eight points on the hyperphagia questionnaire to be considered clinical significant and meaningful...theirs isn’t...not a giant signal. — KOL in the PWS field; involved with Soleno's clinical program",
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      "text": "Source: Scorpion Capital consultation calls with experts",
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