Manufacturing And SupplyConfirmed commercial registration batches and scalable domestic production capacity position the company to address U.S. ketamine shortages and support product launch readiness.
Real-world EvidenceA very large real-world dataset covering tens of thousands of ketamine treatments strengthens the efficacy and safety case and reduces reliance on new clinical trials for regulatory review.
Regulatory PathwayFDA signaled willingness to review a combined package of prior controlled trials plus a large real-world dataset, creating a clear path to file an NDA for the IV ketamine candidate under a streamlined regulatory pathway.