Not admitted · Not a forecast
Rules 1.1.0 · as of 14 Sep 2026
Owen Scott Muir · Said 5 Jun 2024 · owen-1067
Quote
Not a forecast
“Just because the FDA accepts your New Drug Application for review does not mean they think it's a good idea, nor are they likely to approve it.”
Part I of the MDMA-AT series, 'Submitted data' section, discussing Breakthrough Status and the FDA's acceptance of the Lykos New Drug Application. The author states as a general point that FDA acceptance of an NDA for review does not mean the agency thinks it is a good idea, nor that it is likely to approve it.
Descriptive, retrospective, or a statement of preference; no future state asserted.