U.S. Intern Study: Protocol Passes 30-Day FDA Review Period, Cleared for Initiation

On March 27, the study protocol for our upcoming U.S. intern study of MDMA-assisted psychotherapy for PTSD was cleared for initiation by the FDA after we received no response during the mandated 30-day review period. We contacted the FDA to verify the status of the protocol and learned that they are very busy and we should hear from them in about three weeks. Our research team originally submitted the protocol to the FDA on February 27. This is not a setback, since the study physician is still waiting on his Schedule I license from the DEA.