The FDA (the US drug regulator) already rejected MDMA-assisted therapy once, asking for more evidence. Experts now predict the FDA will require either extra studies or strict safety rules before it ever says yes. The core concern: in the trials so far, patients could tell whether they got the real drug or a fake one, which makes the results harder to trust.
My mandate is patient protection. Functional unblinding concerns from the prior CRL haven't been resolved by new mechanistic papers. Rigor must be earned.