FDA Grants In-Person Type A Meeting Request to Discuss Clinical Hold on Phase 2 Study of Cannabis for Veterans with PTSD (MJP2)

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 Clinical Hold for Study MJP2 in order to gain agreement on the sufficiency of the safety information to support the proposed dosing paradigm, proposed administration instructions, and inclusion of cannabis-naïve participants. While the FDA has limited availability for face-to-face meetings, the Agency has determined that this meeting falls into one of the prioritized meeting types and granted the request for an in-person meeting. This Type A meeting will take place on June 15, 2023, at the FDA Headquarters in Silverspring, MD. Read the Meeting Granted letter here.