So the Adcomm voted 8-3 against approval….so does this mean an imminent FDA approval ? An Adcomm voted 10-0 against approving a drug for AD….’death’ was a proven side effect…..however the FDA approved that AD drug !!!!!! We are truly at the mercy of an unpredictable bureaucratic beast.
Ann: Rexlemestrocel-L Improves LVEF, Preceding Reduction in MACE, page-296
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