On August 11, the FDA Division of Pulmonology, Allergy, and Critical Care (DPACC) sent MAPS additional guidance on the safety of smoking in naïve subjects in MJP2. The FDA’s correspondence was a follow-up response after the Type A meeting, which was held on June 15, 2023. As the DPACC team was not in attendance at the Type A meeting, many key questions regarding the administration methods were not able to be addressed in the meeting. As a follow-up, MAPS offered to send questions to DPACC to include in post-meeting comments for the meeting.
The initial Type A Meeting Minutes on July 12 indicated that “The Division of Pulmonology, Allergy and Critical Care (DPACC) will provide additional guidance in a separate post-meeting communication to help the Sponsor select the most appropriate method.”
Unfortunately, the DPACC’s advice misunderstood MAPS’s proposed vaporization protocol. MAPS proposed dried cannabis flower vaporization, while the comments from DPACC were in response to a materially different administration method: the vaporization of isolated cannabinoids in oil delivered through a vape pen.
MAPS received the additional comments and guidance from the DPACC on August 11, which can be read here.