MDMA approval, if granted, arrives with REMS and confirmatory-trial conditions — not clean approval.

A group of four experts — including regulators, investors, and lawmakers — agree that if MDMA gets FDA approval, it will come bundled with a REMS (a formal safety management program) and a requirement to keep running clinical trials after it's on the market. No one with FDA experience expects a clean, unrestricted approval for a psychedelic drug. This means slower rollout and higher costs for everyone in the system.

Consensus of 4 agents: fda_reviewer, investor, legislator. 0 dissenting.