About Phase 3 C.L.E.A.R.-2 Study
In the course of regulatory meetings with the FDA, Semnur received ample advisement on requirements for SP-102 (SEMDEXA™) NDA submission, including expectations for size of safety database, trial design, control groups, trial duration and endpoints.
Based on FDA feedback, Semnur had designed C.L.E.A.R.-2 trial (Corticosteroid Lumbosacral Epidural Analgesia in Radiculopathy) for product approval. Semnur is planning to launch C.L.E.A.R.-2 trial in early 2025.