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  "documentTitle": "Soleno Therapeutics (SLNO)",
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  "presentationDate": "2025-08-15 00:00:00",
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      "text": "The investigator thoroughly trashed Vykat and the clinical trials, stating he saw no benefit in any of his enrollees; that he “encouraged them not to continue” into the open-label extension.",
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      "text": "Indicated Vykat is a total failure with no impact on hyperphagia or weight. He expressed surprise that the FDA approved it, attributing it to families’ desperation and “hype” and “not on the basis of effectiveness”; indicated that other investigators and PWS KOL’s in general share his skepticism; and he “would struggle with” the risk of diabetes and other serious adverse effects – “I would very surprised if it’s a blockbuster”; “others who clearly feel closer to how I have felt about it”; “I feel that a treatment is possible, but I don’t think it’s this treatment…Vykat doesn’t do that.”",
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      "text": "Stated that none of his patients improved and in fact tended to keep gaining weight, and that other patients just dropped out. He further indicated that the trial was functionally unblinded due to obvious side effects – “to be frank, my feeling was I don’t think anyone improved”; “so, I have been very skeptical about it”; “we knew he was on DCCR – and he put on a lot of weight...so clearly, this was not effective”; “then another person on the trial, she was putting on weight”",
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      "text": "Expressed strong concerns about the validity and conduct of the trials, in particular the withdrawal study which was the basis of FDA approval. He replied “yes, yes, yes” when we stated that the withdrawal study data seemed too good to be true – “I actually thought it probably wouldn’t be approved...I thought they would be much tougher...and I think there was a very powerful campaign [by associations/families]...families are desperate to see treatment.”",
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      "text": "The investigator thoroughly trashed Vykat and the clinical trials, stating he saw no benefit in any of his enrollees; that he “encouraged them not to continue” into the open-label extension; that only one patient remains on drug, for a discontinuation rate of ~80%; and that he is skeptical of the mother’s perception of benefit in the one remaining patient on the drug.",
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      "text": "“publishing in this area for 20 or 30 years” — Trial investigator #3; “very much involved with Soleno over the years” — Trial investigator #3; “I’m asked to speak to parents, but quite often I speak to clinicians.” — Trial investigator #3; “encouraged them not to continue” — Trial investigator #3; “not on the basis of effectiveness” — Trial investigator #3; “would struggle with” — Trial investigator #3; “I would very surprised if it’s a blockbuster” — Trial investigator #3; “others who clearly feel closer to how I have felt about it” — Trial investigator #3; “I feel that a treatment is possible, but I don’t think it’s this treatment...Vykat doesn’t that.” — Trial investigator #3; “to be frank, my feeling was I don’t think anyone improved” — Trial investigator #3; “so, I have been very skeptical about it” — Trial investigator #3; “we knew he was on DCCR - and he put on a lot of weight...so clearly, this was not effective” — Trial investigator #3; “then another person on the trial, she was putting on weight” — Trial investigator #3; “yes, yes, yes” — Trial investigator #3; “I actually thought it probably wouldn’t be approved...I thought they would be much tougher...and I think there was a very powerful campaign [by associations/families]...families are desperate to see treatment.” — Trial investigator #3",
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      "text": "Source: Scorpion Capital consultation calls with experts",
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      "kind": "title",
      "text": "Trial investigator #3: Longtime, globally-recognized authority on Prader-Willi Syndrome; “publishing in this area for 20 or 30 years” with a particular focus on hyperphagia; extensively involved with key PWS associations in advisory or leadership roles; “I’m asked to speak to parents, but quite often I speak to clinicians.” Has a long history with Soleno – “very much involved with Soleno over the years” – including the phase 3, open-label, and withdrawal studies.",
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