Today, MAPS received the initial set of comments of the IRC-IRB. My initial impression is that we will eventually be able to get some protocol approved, but that we might need to limit enrollment to more severe PTSD patients who have failed on psychotherapeutic treatments as well as an SSRI, and are 21 or older.
We have been requested by the new IRB to provide a substantial amount of additional information. We hope to submit our response within several weeks for the next review, which Dr. Michael Mithoefer and I will probably attend on either January 28 or February 4. Despite the additional work that is ahead of us, it’s a profound relief that the new IRB is willing to approach this issue based on the science.