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      "text": "The ex-employee fears Vykat may be a looming safety disaster and encouraged us to scrutinize the withdrawal study upon which FDA approval was based, as the phase 3 failed, as far too short to capture the aftermath of long term use, among other red flags.",
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      "text": "I think something that you might want to pay a little attention to...the randomized withdrawal approach...you kind of look at things in a pretty short time frame for what could be a potentially lifetime drug use. You just don't know what will happen over the next several years. The side effects of the drug that require it to be up-titrated very slowly are a challenge. And I'm not going to give any confidential information, but you can tell from the package insert and the publications that some of the side effects, like the hyperglycemia and edema, are not particularly benign conditions. Part of the reason you don't want people to become obese is so that they don't get diabetes and hyperglycemia and things like that. And if you have to bump up somebody's metformin and all that just to deal with the drug, it's okay to do it for a few weeks, a few months. But when you say, I'm going to have hyperglycemia for very long periods, then you don't know what's going to happen to your kidneys and eyes over time. And also the very long list of excluded drugs because of the cytochrome liability. I think there's a Cyp1a2 and CYP3a4 and an inducer as well as the inhibitor, it can have quite a difficult effect on how to prescribe and how to navigate.",
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      "text": "“I think something that you might want to pay a little attention to...the randomized withdrawal approach...you kind of look at things in a pretty short time frame for what could be a potentially lifetime drug use. You just don’t know what will happen over the next several years. The side effects of the drug that require it to be up-titrated very slowly are a challenge...the side effects, like the hyperglycemia and edema, are not particularly benign conditions...And if you have to bump up somebody’s metformin and all that just to deal with the drug, it’s okay to do it for a few weeks, a few months. But when you say, I’m going to have hyperglycemia for very long periods, then you don’t know what’s going to happen to your kidneys and eyes over time. And also the very long list of excluded drugs because of the cytochrome liability. I think there’s a Cyp1a2 and CYP3a4 and an inducer as well as the inhibitor, it can have quite a difficult effect on how to prescribe and how to navigate.” — 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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