Drug Fix: US FDA And Psychedelic Drugs, Aduhelm Clinical Trial Data, Adcomm Candidates

Pink Sheet reporters and editors discuss the FDA’s approach to psychedelic drugs (:25), whether postmarket clinical trial data from the Alzheimer’s drug Aduhelm will be published (16:32), and the FDA offering more time to find candidates for its new Genetic Metabolic Diseases Advisory Committee (27:19).

More On These Topics From The Pink Sheet

Lykos’ MDMA NDA Leads Upcoming Tests Of US FDA’s Psychedelics Draft Guidance: https://pink.citeline.com/PS149813/Lykos-MDMA-NDA-Leads-Upcoming-Tests-Of-US-FDAs-Psychedelics-Draft-Guidance

For Psychedelics, US FDA Is Open To Creative Thinking But Firm On Approval Standards: https://pink.citeline.com/PS149812/For-Psychedelics-US-FDA-Is-Open-To-Creative-Thinking-But-Firm-On-Approval-Standards

A Visual Trip Through The Psychedelic Pipeline: https://pink.citeline.com/PS149831/A-Visual-Trip-Through-The-Psychedelic-Pipeline

Aduhelm’s Post-Marketing Studies: At Least One More Data Dump Likely Required By NIH: https://pink.citeline.com/PS149826/Aduhelms-Post-Marketing-Studies-At-Least-One-More-Data-Dump-Likely-Required-By-NIH

New US FDA Genetic Metabolic Adcomm Needs More Candidates: https://pink.citeline.com/PS149819/New-US-FDA-Genetic-Metabolic-Adcomm-Needs-More-Candidates