FDA Issues Continued Partial Clinical Hold Letter to MAPS for the Open-Label, Multi-Site Research Study of the Safety and Psychological Effects of Manualized MDMA-Assisted Therapy in Healthy Volunteer Therapists (Study MT2)

On September 27, 2019, the U.S. Food and Drug Administration (FDA) replied to MAPS’ complete response to the partial clinical hold placed on Study MT2 by issuing a Continued Partial Clinical Hold Letter, citing the same concerns as the initial letter and concluding that the issues had not been sufficiently resolved.