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  "documentTitle": "Soleno Therapeutics (SLNO)",
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  "presentationDate": "2025-08-15 00:00:00",
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      "text": "He also stated that investigators were kept in the dark and that Soleno was overly “secretive” – “we didn't see much of the data...it was presented more to use as one might...in a paper or presentation...a sort of group data...we didn't get feedback on our own individual participants...more secretive than they should have been.”",
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      "text": "He stated that all his enrollees were on active drug, which he was able to deduce; and that families knew if they were on drug on placebo as the Vykat tablet has a smell – “the actual active drug smelled a bit, and it smelled differently from the placebo...and the message went around, and people could tell that it was the active drug.” He was further skeptical of the purported improvements reported in Soleno’s trials – “those improvements happening late into the trial and in the open phase...if the improvement is fundamentally happening in the open phase, then that’s problematic.” He also stated that investigators were kept in the dark and that Soleno was overly “secretive” – “we didn’t see much of the data...it was presented more to use as one might...in a paper or presentation...a sort of group data...we didn’t get feedback on our own individual participants...more secretive than they should have been.”",
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      "text": "Various problems with the trials: unblinded due to tablet smell; purported open label improvements are “problematic”\nA: “Are there problems with the trial? And what one is seeing is distortions because people know that —”\nQ: “Did you observe any distortions in the trial around unblinding, HQ-CT scores? An investigator I talked to said the score is not reliable.”\nA: “I think there’s been a lot of discussion about it. In fact, I think in reality, the [approximately five] patients that we saw turned out all to be on the active drug effect. Now, there was a story that the actual active drug smelled a bit, and it smelled differently from the placebo. And the message went around, and people could tell that it was the active drug. I don’t know whether the people involved, the parents in our case, knew, had guessed and guessed correctly that their son or daughter was on the active drug. That never actually came up in discussion. They never said, oh, I’m convinced my son or daughter is on the drug. I think that leads to another problem that one of the arguments is that the improvements in hyperphagia, what we’re now seeing is those improvements happening late into the trial and in the open phase. And it seems to me, if the improvement is fundamentally happening in the open phase, then that’s problematic.” - Trial investigator, key opinion leader for PWS",
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      "text": "PI didn’t see “much of the data”: company was overly “secretive”\n“I think it’s fair to say that we didn’t see much of the data as it was coming through. It was presented more to us as one might try and present it in a paper or presentation, a sort of group data. So, we didn’t get feedback on our own individual participants other than to say, ultimately, to break the code as to whether they were active or placebo in groups...maybe they were more secretive than they should have been.” - Trial investigator, key opinion leader for PWS",
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      "text": "“the actual active drug smelled a bit, and it smelled differently from the placebo...and the message went around, and people could tell that it was the active drug.” — Trial investigator, key opinion leader for PWS",
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      "text": "Source: Scorpion Capital consultation calls with experts",
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      "text": "Trial investigator #3 highlighted various red flags in the trials – “distortions” – such as functional unblinding.",
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