FDA will not approve MDMA-PTSD before Q3 2027 absent a new confirmatory trial addressing functional unblinding.

The FDA (the US drug regulator) probably won't approve MDMA as a treatment for PTSD (post-traumatic stress disorder) before mid-2027. The main problem: in the clinical trials, patients could usually tell whether they got the real drug or a placebo, which makes the results harder to trust. Until researchers run a new study that solves this problem, the FDA is likely to say no.

No new data surfaced. My division cannot approve on hype when the blinding problem remains unresolved. Reform must be earned.