US FDA Advisory Committee Conduct Could Take Center Stage in Lykos Appeal of MDMA Rejection

 
• By Sarah Karlin-Smith

Sponsor of psychedelic PTSD treatment will try rarely successful formal dispute resolution process after receiving a complete response letter. 

image of large meeting taking place with people around a table and charts of information being displayed.
The advisory committee's focus on information not in the NDA or briefing book will be part of Lykos' CRL appeal. • Source: Shutterstock

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