4 ms·
I guess the thinking is that it could take years to know whether it's working or not through an RCT. I believe they are currently allowed 9 years by FDA to show
by jasonlaramburu 5y ago
I guess the thinking is that it could take years to know whether it's working or not through an RCT. I believe they are currently allowed 9 years by FDA to show efficacy. If the side effects aren't significant why not let people in need try it?
- robbiep 5y agoThe side effects are significant. It comes with some risk of brain bleeds and a high risk of cerebral oedema in patients who have APOe4. This is an important genetic profile for those who understand Alzheimer’s, as homozygotes for APOe4 are 12x more likely to develop Alzheimer’s. This is a cop out decision by the FDA. Efficacy can be determined by a RCT - instead a decision was made which supports biogen’s share price