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by dredmorbius
836 days ago
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In this case, the FDA had approved the drug, though conditionally. Second 'graph of TFA: A second advisory committee meeting was convened, and if that phrase sounds odd to you, it should. That's a very unusual thing to do. This one voted for approval, and the FDA did approve the drug in September of 2022. There was a condition, though: Amylyx was already working on a Phase III trial, and they committed to withdrawing the drug if this trial showed no efficacy. |
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