Not admitted · Not a forecast
Rules 1.1.0 · as of 14 Sep 2026
Owen Scott Muir · Said 26 Jun 2024 · owen-1140
Quote
Not a forecast
“But you're not guaranteed that approval at that first meeting. Sometimes, it's gonna take years.”
Lesson drawn from the flibanserin (Addyi) history (NDA 2009, denials, approval with REMS in 2015) and applied to MDMA-AT: approval is not guaranteed at the first decision and can take years.
Descriptive, retrospective, or a statement of preference; no future state asserted.