MAPS Requests Meeting with FDA 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)

Unable to resolve these hold issues without substantive feedback from the FDA, MAPS submitted a formal “Type A Meeting Request” on April 20, 2020. This formal meeting request asked the FDA reviewers to meet with MAPS to discuss the hold issues in an effort to resolve the concerns and facilitate the removal of the clinical hold for Study MT2.