Preparation of Final Report to FDA on Initial MDMA/PTSD Study

From Sept. 27 to Oct. 1, Clinical Research Associate Berra Yazar-Klosinski, Ph.D. and Clinical Program Manager Amy Emerson were in Charleston, SC, where they archived the research data from our first U.S. MDMA/PTSD pilot study for long-term storage in preparation for any FDA audits. The documents have also been duplicated for security measures in case any were damaged or destroyed. Berra, Amy, Ilsa Jerome, and the Mithoefers are working on a comprehensive Final Clinical Study Report for the FDA, which is set to be finished and submitted early next year. It will contain detailed information about everything relevant to the study, such as how it was conducted, how we worked with the Institutional Review Board (IRB), how and what we communicated to the FDA and the DEA, and all of the data, both analyzed and in its raw form. The FDA may conduct an independent analysis of the raw data to verify our conclusions. Essentially, “the final report is a pretty wrapped package of the entire clinical trial,” according to Berra.