FDA Denies Meeting Request to Resolve Hold Issues on Open-Label, Multi-Site Research Study of the Safety and Psychological Effects of Manualized MDMA-Assisted Therapy in Healthy Volunteer Therapists (MT2)

On April 30, 2020, the U.S. Food and Drug Administration (FDA) quickly and succinctly denied MAPS’ request for a meeting to resolve the clinical hold issues, citing that the meeting request did not propose to discuss new information.