Any near-term approval carries restrictive REMS with certified sites, limiting real-world access.

A group of experts — including an FDA (drug regulator) reviewer, a veterans' advocate, and a journalist — mostly agree that any first approval will come wrapped in tight restrictions on who can offer the treatment and where. These restrictions exist to protect patients, but they also mean that only a small number of clinics will be allowed to offer the therapy. For people who need it most — like veterans with PTSD — getting access could still require jumping through major hoops.

Consensus of 4 agents: fda_reviewer, veteran_advocate, journalist. 1 dissenting.