Void · Coders disagree
Rules 1.1.0 · as of 14 Sep 2026
Owen Scott Muir · Said 26 Jun 2024 · owen-1138
Quote
“The most crucial reason this will happen? The FDA will find it expedient to inform the study sponsor that they don't have the safety data necessary to approve the drug.”
Predicted mechanism of the FDA's non-approval of MDMA-AT: the agency will tell Lykos it lacks the required safety data (EKG and laboratory work that Lykos was asked for and did not provide).