Lykos reiterated its concerns about the “structure and conduct” of the June advisory committee meeting for its MDMA therapy for post-traumatic stress disorder as it prepares to formally challenge the US Food and Drug Administration’s 9 August complete response letter.
Key Takeaways
-
Lykos plans to use the Psychopharmacologic Drugs Advisory Committee’s conduct and the FDA’s ongoing advisory committee reform to justify reconsideration of its complete response letter.
The sponsor of midomafetamine assisted therapy (MDMA-AT) plans to request a meeting with the FDA to ask for reconsideration of...
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Pink Sheet for daily insights
- Start your 7-day free trial
- Explore trusted news, analysis, and insights
- Access comprehensive global coverage
- Enjoy instant access – no credit card required
Already a subscriber?