FDA Approves Revised Protocol; Documents Prepared for IRB

On July 8, 2013, the U.S. Food and Drug Administration fully approved the amended protocol for our planned study of MDMA-assisted therapy for social anxiety in adults on the autism spectrum, to be led by Principal Investigator Charles Grob, M.D., and Alicia Danforth, Ph.D., at Harbor-UCLA Medical Center/Los Angeles Biomedical Research Institute. In their first review, the FDA requested several changes to the subject screening and enrollment process. In our June 4 response, we presented a clear scientific argument for why we did not feel those changes were necessary; significantly, the FDA found our argument persuasive and approved the protocol. We are now preparing to submit the study protocol and related documents for review by the Institutional Review Board at the study site.