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Multidisciplinary Association for Psychedelic Studies – MAPS

Multidisciplinary Association for Psychedelic Studies - MAPS

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MJP2

MAPS Submits Cannabis Data Safety Update Report 2024 and Protocol Amendment to FDA on Phase 2 Study of Smoked Cannabis for Veterans with PTSD (MJP2)

On January 15, 2025, MAPS submitted to the FDA the 2024 Cannabis Data Safety Update Report (DSUR) along with a protocol amendment. The DSUR serves as the FDA Annual Report on the progress of the drug …
January 15, 2025

MAPS cleared to proceed by FDA on Phase 2 Study of Smoked Cannabis for Veterans with PTSD (MJP2)

On November 7, 2024, MAPS received notice from the FDA that the Phase 2 study of Cannabis for Veterans with PTSD (MJP2) is cleared to proceed with smoking as a delivery method. This update confirms that …
November 7, 2024

MAPS submits sixth Clinical Hold Response to FDA on Phase 2 Study of Cannabis for Veterans with PTSD (MJP2)

On October 10, 2024, MAPS submitted a Complete Response to FDA’s Clinical Hold on Phase 2 Study of Cannabis for Veterans with PTSD (MJP2). This response addressed the four key clinical hold issues identified …
October 10, 2024

MAPS achieves agreement on three key points despite “Appeal Denied” letter received from FDA on Phase 2 Study of Cannabis for Veterans with PTSD (MJP2)

On September 19, 2024, MAPS received the response from the Office of Neuroscience to the Formal Dispute Resolution Request (FDRR) submitted by MAPS on August 23, 2024. The FDRR was submitted in response …
September 19, 2024

MAPS Submits Formal Dispute Resolution Request Against FDA’s Clinical Hold on Phase 2 Study of Cannabis for Veterans with PTSD (MJP2)

On August 23, 2024, MAPS submitted a Formal Dispute Resolution Request to appeal the Clinical Hold placed on the Phase 2 study of cannabis for Veterans with PTSD (MJP2) by the FDA Division of Psychiatry …
August 23, 2024

MAPS Submits Cannabis Data Safety Update Report 2023 to FDA on Phase 2 Study of Smoked Cannabis for Veterans with PTSD (MJP2)

On January 11, 2024, MAPS submitted to the FDA the 2023 Cannabis Data Safety Update Report (DSUR). The DSUR serves as the FDA Annual Report on the progress of the drug investigation over the last year. …
January 11, 2024
Multidisciplinary Association for Psychedelic Studies – MAPS
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