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      "text": "I find it difficult to think that they will be able to really penetrate even a limited market just because of the adverse effects, the need for very, very close monitoring...how that plays out in terms of the kids not gaining weight over the next five years and having a more normal life, I just don't know because I don't think that data exists.",
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      "text": "The ex-employee expressed surprise that the drug was approved – “very candidly…I’m kind of surprised that the FDA gave them an approval” – and indicated the trials were functionally unblinded because obvious side effects like hair growth and edema, and because patients’ families deduced that Vykat pills smelled different than placebo – “that was the challenge with this compound all the way…the stock has gone up astronomically…but I find it difficult to think that they will be able to really penetrate even a limited market just because of the adverse effects, the needs for very, very close monitoring…how that plays out in terms of the kids…I don’t think that data exists”; “with a completely soft endpoint, it’s very tricky and it’s very hard to blind yourself…just from the side effects, it’s pretty clear whether you’re on active drug or not.”",
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      "text": "“Surprised” at FDA approval; issues with largest trial site; trial was essentially unblinded\n“Very candidly…I’m kind of surprised that the FDA gave them an approval. And I don’t know if they audited Jennifer Miller’s site. But with a completely soft endpoint, it’s very tricky and it’s very hard to blind yourself to this drug. You can say I’m on placebo or whatever, but just from the side effects, it’s pretty clear whether you’re on active drug or not. It’s really challenging to blind.” – Ex-Soleno employee #1, key role in clinical trial program",
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      "text": "Trials were functionally unblinded; won’t penetrate an already tiny market; “don’t think that data exists” to show it helps PWS\nQ: “Several investigators have said they thought the trial was functionally unblinded because the side effects — the hair growth, the edema — it seems like a lot of parents apparently were trading notes on like on some WhatsApp or Facebook group. They were saying that the DCCR smelled different than placebo. I don’t know if that’s accurate or not. I mean, even a little bit of functional unblinding in the context of a caregiver questionnaire can make a trial completely useless.”\nA: “Yes, completely. I agree with you. And I think that was the challenge with this compound all the way. And the stock has gone up astronomically since they got the last Phase 3 result and the and the approval from the FDA. But I find it difficult to think that they will be able to really penetrate even a limited market just because of the adverse effects, the need for very, very close monitoring…how that plays out in terms of the kids are not gaining weight over the next five years and having a more normal life, I just don’t know because I don’t think that data exists.” – Ex-Soleno employee #1, key role in clinical trial program",
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      "text": "Very candidly...I'm kind of surprised that the FDA gave them an approval. And I don't know if they audited Jennifer Miller's site. But with a completely soft endpoint, it's very tricky and it's very hard to blind yourself to this drug. You can say I'm on placebo or whatever, but just from the side effects, it's pretty clear whether you're on active drug or not. It's really challenging to blind. — 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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