Module 2.7.5 — Literature References (OBX-319)

Document ID: M275
Version: 1.0
Change History: 1.0 — Initial issue.
Standard(s): ICH M4E(R2)

2.7.5 Literature References — OBX-319

Key references cited across the clinical summaries for OBX-319 in Systemic Lupus Erythematosus (moderate-to-severe active), including the disease epidemiology and unmet need, the bispecific monoclonal antibody mechanism and class data, the endpoint validation (SLEDAI-2K), and the relevant regulatory guidance. Full citations accompany each Module 2.5/2.7 and Module 5 document.