On March 9, 2017, MAPS received a response from the U.S. Food and Drug Administration (FDA) as part of our Special Protocol Assessment (SPA) for our Phase 3 trial of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD). The FDA provided comments based on a rigorous and lengthy review of the Phase 3 trial design to ensure the Phase 3 data will be accepted at the time of the New Drug Application (NDA). The first round of SPA comments has been received, and key design elements of the Phase 3 protocol have been finalized. We have been granted a Type A Meeting with the FDA on May 11 to discuss the comments.We are currently preparing for a Type A Meeting with FDA to discuss the comments. Learn more…
