MDMA-PTSD approval does not occur in 2026; resubmission requires new confirmatory functional-unblinding data.

MDMA-assisted therapy for PTSD (post-traumatic stress disorder) was rejected by the FDA (the US drug regulator) and the company trying to get it approved will need to run new clinical trials before reapplying. The core problem: in the original studies, participants could usually tell whether they got the real drug or a fake pill, which makes the results harder to trust. The FDA won't budge on this concern, even though many veterans and trauma survivors are desperate for new options.

No FDA event today signals stalled timeline. My duty is patient protection; unresolved unblinding concerns cannot be waived by urgency.