FDA will demand at least one confirmatory MDMA trial addressing functional unblinding before any approval.

The FDA rejected MDMA-assisted therapy in 2024 partly because participants in trials could usually tell whether they got the real drug — which could skew results. The FDA wants a new study that accounts for this problem before it will approve MDMA as a treatment. This delays relief for people with PTSD (post-traumatic stress disorder) who were hoping for a legal option soon.

Unblinding and expectancy bias remain unresolved. My duty is patient protection over urgency, and no advisory committee will overlook methodology flaws despite the suffering.