On May 23, 2022, MAPS submitted a complete response to the U.S. Food and Drug Administration (FDA) addressing the concerns outlined in the continued partial clinical hold for MAPS-sponsored Study MPG1. …
On April 15, 2022, the U.S. Food and Drug Administration (FDA) upheld a partial clinical hold on Study MPG1, preventing the study from being initiated. FDA did not address specific questions from the previous …
On March 17, 2022, MAPS submitted a complete response to the U.S. Food and Drug Administration (FDA) addressing the partial clinical hold issues in the MAPS-sponsored Study MPG1. The response upheld that …
On February 28, 2022, the U.S. Food and Drug Administration (FDA) placed Study MPG1 on partial clinical hold, preventing the study from being initiated. FDA highlighted their concerns in the Partial Clinical …
MAPS has not received any official FDA communication on MPG1. On 13 January, the FDA informed us with a brief courtesy email that the MPG1 protocol was not yet reviewed, and they hope to review it soon. …
On December 8, 2021, the 30 day protocol review period passed for our open-label feasibility and safety study of MDMA-assisted group therapy for the treatment of posttraumatic stress disorder in Veterans …
On November 8, 2021, MAPS submitted a new study protocol to the U.S. Food and Drug Administration (FDA) for a Phase 2 open-label feasibility and safety study of MDMA-assisted group therapy for the treatment …
On November 2, 2021, the U.S. Food and Drug Administration (FDA) granted MAPS PBC’s request for rolling submission and review of portions of our planned new drug application (NDA) for MDMA. Rolling …
