3 ms·
For those eventually reading the above comment at some point - I honestly forgot that the accelerated approval process exists, and that’s how this got approved.
by epmaybe 5y ago
For those eventually reading the above comment at some point - I honestly forgot that the accelerated approval process exists, and that’s how this got approved. That basically means they get to say their drug was shown to affect surrogate markers (in this case, brain amyloid levels) and thus could be effective at treating symptoms, even though the trial was ended for futility.
Feels like gaming the system in a way, and you can still market this very effectively without saying it can treat Alzheimer’s..”our drug was shown to reduce X, a key marker in Y”. I hate direct to consumer drug marketing.