Module 1 (KR) — IND / Application Summary (OBX-319)

Document ID: M1-KR-IND
Version: 1.0
Change History: 1.0 — Initial issue.
Standard(s): MFDS

Korea (MFDS) IND / Application Summary — OBX-319

Summary supporting the MFDS submission for OBX-319 in Systemic Lupus Erythematosus (moderate-to-severe active) (study OBX319-301), aligned to the CTD and MFDS regional requirements. MFDS notification; ICH.