Clinical Efficacy And DurabilityCOMP360 produced rapid and sustained reductions in depressive symptoms in pivotal trials, indicating a durable treatment effect that may support strong clinical uptake.
Regulatory Pathway ClarityRegulatory engagement and plans for a rolling new drug application create a clearer approval pathway and reduce binary regulatory risk.
Reimbursement And Delivery InfrastructureNew procedural billing codes combined with leveraging existing interventional psychiatry sites lower reimbursement and operational hurdles, improving commercial feasibility.