Not admitted · Not a forecast
Rules 1.1.0 · as of 14 Sep 2026
Christian Angermayer · Said 5 Jun 2024 · angermayer-0183
Quote
Not a forecast
“It isn't MDMA itself that was rejected per se, but the specific, poor data set provided by Lykos; the committee particularly cited discrepancies in clinical trial design + conduct, inadequate collection of safety + other relevant data, bias in the evaluation of patients, and cases of patient abuse during the trials.”
Two months before the FDA action on the Lykos NDA, he states the problem is the Lykos data package and names inadequate safety data collection as a cited defect.
Descriptive, retrospective, or a statement of preference; no future state asserted.