Expedited Program Requests (OBX-319)

Document ID: DESIG-001
Version: 1.0
Change History: 1.0 — Initial issue.
Standard(s): FDA/EMA expedited

Expedited Program Requests — OBX-319

Evaluation and, where supported, requests for expedited programs for OBX-319 in Systemic Lupus Erythematosus (moderate-to-severe active) (Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review; EU PRIME/accelerated assessment; orphan designation as applicable), with the qualifying rationale.