In September, MAPS submitted an application to FDA for a new study evaluating psilocybin-assisted psychotherapy for subjects with end-of-life anxiety secondary to advanced-stage melanoma. On October 18, we learned that the study will receive clearance from FDA, with only one clinical hold due to a request from FDA for a stability study of the psilocybin. The study was conducted earlier this month, and the results showed that the psilocybin is 100% pure. The results will be submitted to FDA soon. Earlier this month, we also submitted the protocol to an IRB, where it is currently under review.
