FDA Sends the Official Minutes of Type A Meeting for Phase 2 Study of Cannabis for Veterans with PTSD (MJP2)

On July 12, 2023, the FDA Division of Psychiatry sent MAPS the official minutes of our Type A meeting on June 15, 2023. The Type A meeting focused on the issues the FDA cited in its Clinical Hold on the MJP2 study protocol. MAPS and the FDA discussed strategies to resolve the cited issues so the study can move forward. The FDA has not yet submitted the comments from its pulmonary team, which the FDA project manager indicated MAPS would receive before the end of July. MAPS’ next step is to submit a revised protocol. Read the Type A Meeting Minutes here.