Ep. 387 - Psychedelics at FDA, Mike Davis’ CDER & tRNAs

FDA has laid out what it will accept to approve a psychedelic therapy: 12-week efficacy data plus preliminary follow-up. On the latest BioCentury This Week podcast, BioCentury's analysts assess what that means for sponsors navigating trial design with the agency.The team also discusses Michael Davis' first interview as permanent CDER director and what it signals for regulatory stability after a turbulent year, plus preclinical advances positioning suppressor tRNAs as a platform for Duchenne, cystic fibrosis, and other nonsense-mutation diseases. Also this week, emerging company profiles on BrainChild and Cloverleaf.View full story: https://www.biocentury.com/article/660792#Psychedelics #FDA #GeneTherapy #ClinicalTrials #DrugDevelopment0:00 - Introduction1:13 - Psychedelics at FDA10:20 - Mike Davis Leads CDER22:29 - Suppressor tRNAs AdvanceTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text