A Phase 1, Open-Label, Multi-Site Study to Assess Psychological Effects of MDMA-Assisted Therapy When Administered to Healthy Volunteers Timeline (MT2)

MAPS Wins Appeal and Authorization to Study MDMA in Healthy Volunteer Therapists

May 21, 2021
FDA Removes Partial Clinical Hold on Open-Label, Multi-Site Research Study of the Safety and Psychological Effects of Manualized MDMA-Assisted Therapy in Healthy Volunteer Therapists (Study MT2)

May 11, 2021
MAPS Submits Final Formal Request to Remove Clinical Hold Due to Successful Appeal in Formal Dispute Regarding Open-Label, Multi-Site Research Study of the Safety and Psychological Effects of Manualized MDMA-Assisted Therapy in Healthy Volunteer Th

April 26, 2021
FDA Grants Appeal in Formal Dispute Resolution Regarding Open-Label, Multi-Site Research Study of the Safety and Psychological Effects of Manualized MDMA-Assisted Therapy in Healthy Volunteer Therapists (Study MT2)

April 16, 2021
MAPS and FDA Hold Formal Dispute Meeting to Discuss Clinical Hold on Open-Label, Multi-Site Research Study of the Safety and Psychological Effects of Manualized MDMA-Assisted Therapy in Healthy Volunteer Therapists (Study MT2)

January 16, 2021
MAPS Submits Formal Dispute Resolution Request (FDRR) to FDA Regarding Clinical Hold on Open-Label, Multi-Site Research Study of the Safety and Psychological Effects of Manualized MDMA-Assisted Therapy in Healthy Volunteer Therapists (Study MT2)

December 2, 2020
A Phase 1, Open-Label, Multi-Site Study to Assess Psychological Effects of MDMA-Assisted Therapy When Administered to Healthy Volunteers (MT2)

July 7, 2020
FDA Denies Meeting Request to Resolve Hold Issues on Open-Label, Multi-Site Research Study of the Safety and Psychological Effects of Manualized MDMA-Assisted Therapy in Healthy Volunteer Therapists (MT2)

April 30, 2020
MAPS Requests Meeting with FDA to Resolve Hold Issues on Open-Label, Multi-Site Research Study of the Safety and Psychological Effects of Manualized MDMA-Assisted Therapy in Healthy Volunteer Therapists (MT2)

April 20, 2020
The U.S. Food and Drug Administration (FDA) Continues Clinical Hold on Open-Label, Multi-Site Research Study of the Safety and Psychological Effects of Manualized MDMA-Assisted Therapy in Healthy Volunteer Therapists (Study MT2)

January 31, 2020
MAPS Provides Additional Response to FDA Regarding Clinical Hold for the Open-Label, Multi-Site Research Study of the Safety and Psychological Effects of Manualized MDMA-Assisted Therapy in Healthy Volunteer Therapists (Study MT2)

January 1, 2020
MAPS Responds to FDA Regarding Continued Partial Clinical Hold for Open-Label, Multi-Site Research Study of the Safety and Psychological Effects of Manualized MDMA-Assisted Therapy in Healthy Volunteer Therapists (Study MT2)

October 12, 2019
FDA Issues Continued Partial Clinical Hold Letter to MAPS for the Open-Label, Multi-Site Research Study of the Safety and Psychological Effects of Manualized MDMA-Assisted Therapy in Healthy Volunteer Therapists (Study MT2)

September 28, 2019
MAPS Submits a Complete Response Addressing the Partial Clinical Hold for Open-Label, Multi-Site Research Study of the Safety and Psychological Effects of Manualized MDMA-Assisted Therapy in Healthy Volunteer Therapists (Study MT2)

August 30, 2019
FDA Places Open-Label, Multi-Site Research Study of the Safety and Psychological Effects of Manualized MDMA-Assisted Therapy in Healthy Volunteer Therapists (Study MT2) On Clinical Hold

August 6, 2019
MAPS Submits Study Protocol for Open-Label, Multi-Site Research Study of the Safety and Psychological Effects of Manualized MDMA-Assisted Therapy in Healthy Volunteer Therapists Timeline (Study MT2)

May 22, 2019