The FDA is likely to either demand an additional round of clinical trials before approving MDMA-assisted therapy, or grant a very narrow, heavily restricted approval with strict safety monitoring requirements. This is because trial results had problems — participants could usually tell whether they got the real drug or a placebo, which muddies the data, and long-term effectiveness hasn't been proven. For patients with PTSD (post-traumatic stress disorder), this could mean approval is delayed or access is very limited.
Functional unblinding and durability gaps persist. I won't approve on hype, but a narrow PTSD pathway with strict controls is defensible given suicide mortality.