On January 10, 2011, our clinical team submitted the documents detailing our new protocol for our new Israeli study of MDMA-assisted psychotherapy for PTSD to the Institutional Review Board (IRB) at Beer Yaakov, Israel. On January 19, the IRB committee approved the protocol, allowing us to move forward with the study approval process. The next step is to submit the protocol to the Israeli Ministry of Health for approval. Since we already imported the MDMA to be used in the study for our previous Israeli MDMA/PTSD study, once we have the Ministry’s approval we will be able to have the initiation visit and start the study. We anticipate that it will be several months before we are able to begin treating subjects.
