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      "text": "We think there was a cover-up prior to FDA approval. Now the drug is in the real world with nowhere to hide, versus a tiny rare-disease trial.",
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      "text": "Now the drug is in the real world with nowhere to hide, versus a tiny rare-disease trial. An ex-employee indicated that two patients in the phase 3 trial were hospitalized with potential heart failure; that in one case “admitted because of fluid overload,” which is consistent with Vykat-induced edema; that “it is not reflected” in the paper because “it was not attributed to the drug,” and questioned whether this was appropriate as the patients were young and “didn’t have underlying cardiac disease or renal disease” and “you can’t exclude a causal relationship” – “I believe one of the cases may have been in Harvard and the other one must have been in the UK…but MGH had a patient who was admitted for fluid overload and potential heart failure”; “if you have hyperglycemia and diabetes, and you have edema and heart failure, and I do believe there were a couple of patients hospitalized with heart failure just to reduce appetite, it may not be a risk worth taking…”",
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      "text": "“Couple of patients hospitalized with heart failure” during trials; lacked underlying factors for cardiac risk; A: “...if you have hyperglycemia and diabetes, and you have edema and heart failure, and I do believe there were a couple of patients hospitalized with heart failure just to reduce appetite, it may not be a risk worth taking.” Q: “There were a couple of patients that were hospitalized for heart failure?” A: “I do believe so. In the earlier trials. The Phase 3, the negative trials.” Q: “And did they reflect that in the adverse events table? Hold on. Let me pull up the adverse events table for that.” A: “It is not reflected because I think it was not attributed to the drug. They said there were other factors.” Q: “And did you agree with that assessment?” A: “Well, you can never tell 100%, right, when somebody is on an experimental drug, unless they are popping in and out of the hospital with heart failure every two or three months. When somebody develops it on the drug, there’s always a feeling at the back of your mind that you can’t exclude a causal relationship.” Q: “Were there things there that made you wonder if there might be a causal relationship, like lack of other factors that predispose them to heart disease? This is for younger patients, so it is very surprising. Were there things that put a question mark in your mind?” A: “Again, they didn’t have significant underlying cardiac disease or renal disease. I think they had some kind of intercurrent illness and were admitted because of fluid overload. And they were treated successfully. I believe one of the cases may have been in Harvard and the other one must have been in the UK. But MGH had a patient who was admitted for fluid overload and potential heart failure. And the other patient was in the UK.” - Ex-Soleno employee #1, key role in clinical trial program",
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