After reviewing MAPS’ Type A Meeting Request and Briefing submitted on April 28, the FDA granted MAPS’ meeting request. MAPS and the FDA will have a face-to-face formal meeting to discuss the …
On April 28, 2023, MAPS requested the FDA for a Type A meeting to discuss the clinical hold issues for Study MJP2 in order to overcome the clinical hold deficiencies. This meeting request is in response …
On March 14, 2023, MAPS released a progress report for Phase 2 Study of Cannabis for Veterans with PTSD (MJP2). Read the Q4 2022 progress report here.
On January 19, 2023, the FDA advised MAPS that cannabis used in clinical trials is defined as a drug product, rather than a botanical raw material, for the purposes of microbiological testing acceptance …
On December 16, 2022, the FDA advised MAPS that the Partial Clinical Hold placed on our Phase 2 Study of Cannabis for Veterans with PTSD (MJP2) would be continued due to “insufficient information …
On November 16, 2022, MAPS submitted a revised protocol to the FDA in response to hold issues identified in the Agency’s Continued Partial Clinical Hold letters dated May 10 and December 27, 2021. …
On October 15, 2022, MAPS released a progress report for Phase 2 Study of Cannabis for Veterans with PTSD (MJP2). Previous progress reports were released for quarters ending in January, April, and July. …
On August 30, 2022, the FDA responded to MAPS’ request to lift the clinical hold placed on our Phase 2 Study of Cannabis for Veterans with PTSD (MJP2), citing an incomplete response to the hold. …
On August 16, 2022, MAPS submitted a complete response to the FDA addressing the continued partial clinical hold letter, received on December 27, 2021.
On July 21, 2022, a general medical and psychiatric practice in Steinheim, Germany, released a statement about their use of cannabis to treat patients with symptoms of posttraumatic stress disorder (PTSD). …
On July 15, 2022, MAPS released a grant progress report for our Phase 2 Study of Cannabis for Veterans with PTSD (MJP2). Previous grant reports were released in January and April. Read the July 2022 grant …
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 …
