MAPS Requests FDA for a Type A Meeting to Discuss Clinical Hold for the Phase 2 Study of Cannabis for Veterans with PTSD (MJP2)

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 to the Agency’s recommendation for a meeting noted in the Partial Clinical Hold Letter dated December 16, 2022. The objective of this meeting is to gain agreement from the Agency on the sufficiency of the safety information to support the proposed dosing paradigm, proposed administration instructions, and inclusion of cannabis-naïve participants. Read the Type A meeting brief here.