MDMA-PTSD will require a resubmission with new confirmatory data before any approval.

The FDA (the US drug regulator) is likely to reject the current MDMA-assisted therapy application for PTSD (post-traumatic stress disorder) and ask for a brand new confirmatory study. The core problem is that trial participants could usually tell whether they got MDMA or a placebo, which makes the results unreliable. Even though veterans and others are suffering and dying, the regulator's job is to make sure treatments actually work before allowing them.

Functional unblinding is a genuine evidentiary flaw, not procedural. My duty is patient protection over urgency, however sympathetic the veteran suicide crisis.