Commercial Infrastructure And Launch ReadinessCOMP360 can leverage the interventional psychiatry network and SPRAVATO-trained sites, lowering provider adoption barriers and enabling faster site preparedness for rollout.
Regulatory ProgressFDA feedback indicates comfort with a pragmatic trial design and acceptance of an IND for a PTSD study, reducing regulatory uncertainty ahead of pivotal Phase 3 readouts.
Reimbursement And Billing ImprovementsNew procedural billing codes and broader monitoring workforce options improve reimbursement mechanics and address prior staffing inefficiencies, enhancing commercial feasibility.