Amended Protocol Submitted to Institutional Review Board and State Advisory Panel

On August 2, 2013, an amended protocol for our upcoming study of MDMA-assisted therapy for social anxiety in autistic adults was submitted to the Institutional Review Board at Harbor-UCLA/Los Angeles Biomedical Research Institute. The IRB review is scheduled to take place on September 25. On August 19, the study protocol and related documents were submitted to the Research Advisory Panel of California (RAPC), formerly the California Research Advisory Panel (CRAP), an additional approval required for research with Schedule I drugs only in California. The RAPC review is scheduled for September 18. Once the IRB and RAPC approve the amended protocol, Principal Investigator Charles Grob, M.D., will apply for a Schedule I license from the Drug Enforcement Administration. Dr. Grob previously held a license for MDMA in the early 1990s when he conducted our first Phase 1 MDMA safety study, and also has a current license for psilocybin for his Heffter Research Institute-sponsored study of psilocybin for anxiety associated with cancer, so we anticipate the DEA will approve his application.