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.
Why would you test something for efficacy before you're sure it's safe? You'll end up testing a bunch of harmful substances that don't actually do anything.
Maybe because the real standard is "the benefits out weigh the risks" you might want a drug that has a 10% chance of harm if it has a 90% chance of benefit, for a condition that is terminal if untreated.
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.