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 exclusion of participant overnight stays for group treatment sessions does not present any unreasonable or significant risk to participants in Study MPG1. MAPS made specific requests for feedback and clarification to better understand any risks the Agency may have identified.
In an effort to address FDA concerns around the safety risk of not requiring overnight stay for participants, the response also included a proposal to modify the protocol to require overnight stay following the first individual treatment session and permit participants to return home following the group session.
MAPS also submitted an additional response addressing the non-hold issues noted in the partial clinical hold letter.