Health Canada has confirmed that an inspection of our Canadian MDMA/PTSD study site will take place on February 10, 2011. The study pharmacist is currently preparing the safe for installation at the pharmacy in Vancouver, BC. The representative from Health Canada will visit the site and confirm that the MDMA capsules to be used in the study can be safely stored and accounted for in the safe, and will verify that the pharmacy and study site are adequately secure according to Canadian regulations. Once the safe installation has been approved, we can apply for the necessary import and export permits to ship the MDMA from Switzerland to Canada.
Since the study protocol already has the full approval of both the Canadian Institutional Review Board (IRB) and Health Canada, we will begin enrolling subjects as soon as the MDMA has been imported into Canada.