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      "text": "The ex-employee’s color is consistent with an attempt to cover-up the cardiac-related hospitalizations, and suggests that the drug’s edema profile - \"fluid overload, fluid imbalance\" - is a looming safety debacle.",
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      "text": "Q: \"Were people alarmed at the company when those hospitalizations happened? Or they just couldn't really talk about it?\" A: \"There was a lot of pressure to not have the investigator assessment to be causally related to the study drug.\" – Ex-Soleno employee #1, key role in clinical trial program",
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      "text": "Q: \"Were there people at the company arguing for the inclusion of those two adverse events, cardiac adverse events in the paper? Or you just knew that you could get fired if you did that?\" A: \"The atmosphere at the company was very much to downplay the adverse effects [...] if you were to follow up with the company, I would really press on what were the hospitalizations of patients in the trials? And to just ignore the causality and just look at what the case -\"",
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      "text": "Q: \"Were there hospitalizations beyond the cardiac situations, or is that what you're referring to?\" A: \"The cardiac the two big ones and, yeah, I think that was the two big ones.\" Q: \"Were there any other minor hospitalizations?\" A: \"They're just written in the label. But, the diabetes, there's a double asterisk footnote under the hyperglycemia. Edema, pulmonary edema. Pulmonary edema you can die from. Right. It's basically heart failure. And it's a footnote.\"",
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      "text": "Patients hospitalized were young; \"atmosphere at the company\" to \"downplay the adverse effects\"; allegedly a \"lot of pressure\" to assess the hospitalization as not related to Vykat",
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      "text": "Q: \"And do you think this was related to the edema?\" A: \"Could be. Fluid overload, fluid imbalance.\" Q: \"And how old were these patients?\" A: \"They were all young. The oldest patients in the trial were under 40...I think people are highly incentivized to downplay things that could be on the fence...when you have a causal relationship, uncertain or not known, then they decide to not include those type of things in publications.\"",
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      "text": "They were all young. The oldest patients in the trial were under 40...I think people are highly incentivized to downplay things that could be on the fence...when you have a causal relationship, uncertain or not known, then they decide to not include those type of things in publications. [...] The atmosphere at the company was very much to downplay the adverse effects [...] if you were to follow up with the company, I would really press on what were the hospitalizations of patients in the trials? And to just ignore the causality and just look at what the company - [...] There was a lot of pressure to not have the investigator assessment to be causally related to the study drug. — 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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