MAPS Submits a Complete Response Addressing the Partial Clinical Hold for Open-Label, Multi-Site Research Study of the Safety and Psychological Effects of Manualized MDMA-Assisted Therapy in Healthy Volunteer Therapists (Study MT2)

On August 29, 2019, MAPS submitted a complete response to the U.S. Food and Drug Administration (FDA) addressing the partial clinical hold issues in the MAPS-sponsored Study MT2. The response supplied supporting data and information on the scientific benefit of Study MT2, clarification on safety measures for participants, and justification and rationale for allowing licensed therapists with masters level, not doctoral level, degrees to serve as Lead Facilitator with a physician on-call.