Not admitted · Not a forecast
Rules 1.1.0 · as of 14 Sep 2026
Owen Scott Muir · Said 6 Jun 2024 · owen-1069
Quote
Not a forecast
“Doblin’s vision for spiritual healing, gassed up by MDMA, sold as a combo therapy product, was missing the traditional safety assessments required by the FDA to approve any drug —including the necessary liver, heart, and kidney safety, as well as evaluations of addiction risk, that need to be there for a new drug to be approved”
After the FDA Advisory Committee meeting on Lykos Therapeutics' MDMA-AT application (June 2024), the author says the program lacks the standard safety assessments (liver, heart, kidney, addiction risk) that the FDA requires before approving any new drug. Implicit doubt that MDMA-AT is approved as submitted.
Descriptive, retrospective, or a statement of preference; no future state asserted.