U.S. Veterans Study: Protocol Development Proceeds

Were close to completing the protocol design for our upcoming U.S. MDMA/PTSD study exclusively for veterans of war. We plan to submit this protocol to the FDA in November 2009. A crucial protocol design meeting with Rick Doblin, Ph.D., Michael Mithoefer, M.D. and Ilsa Jerome, Ph.D. took place several weeks ago at Rick’s home office. We will be using the Phase 2 study in veterans to test a possible design for our Phase 3 multi-site studies — our most sophisticated protocol design to date. We will provide more information about details of the protocol in an upcoming email newsletter.