Phase 2 Study of Cannabis for Veterans with PTSD (MJP2) Regulatory Correspondences with FDA

Study MJP2 protocol was initially submitted on March 9, 2021. The study was put on hold by FDA on May 10, 2021 with additional comments for the hold provided on June 3, 2021. MAPS provided FDA with a response letter on November 10, 2021 and an updated response letter on November 29, 2021 that provided responses to only a subset of FDA’s hold letter comments per a follow-up request from the FDA. On December 27, 2021, the FDA continued the partial clinical hold.