Request submitted to FDA to change the location of the treatment sessions

Request submitted to FDA to change the location of the treatment sessions from the Medical University of South Carolina (MUSC) to Dr. Mithoefer’s office. We propose renting a “crash cart” and hiring an emergency room nurse to be on site in the room next to the treatment room for the first five hours of each session, in case Dr. Michael Mithoefer and Annie Mithoefer, R.N. need help responding to an adverse event.