Pre-IND Briefing Book (OBX-319)

Document ID: MTG-PreIND
Version: 1.0
Change History: 1.0 — Initial issue.
Standard(s): FDA meetings

Pre-IND Meeting Briefing Book — OBX-319

Briefing package for the Pre-IND interaction on OBX-319 in Systemic Lupus Erythematosus (moderate-to-severe active): development rationale, the nonclinical package supporting first-in-human dosing, the proposed clinical starting dose and Phase 1 design, and the specific questions for the Agency. FDA meeting guidance.