MAPS and FDA Hold Formal Dispute Meeting to Discuss Clinical Hold on Open-Label, Multi-Site Research Study of the Safety and Psychological Effects of Manualized MDMA-Assisted Therapy in Healthy Volunteer Therapists (Study MT2)

On January 15, 2021, MAPS and FDA held a Type A Formal Dispute Meeting to discuss the continued partial clinical hold on Study MT2. MAPS and counsel presented a summary of the dispute resolution request to members of multiple FDA departments, including the initial reviewing division (the Division of Psychiatry Products), the overseeing deciding office (the Office of Neuroscience), and the intermediary department that oversees the FDRR process for these types of interactions. This meeting allowed MAPS an additional forum to present the arguments to each point of the clinical hold, and importantly, to answer questions from the officials at the FDA to help resolve discrepancies or points of concern.