Pre-NDA/BLA Briefing Book (OBX-319)

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

Pre-NDA/BLA Meeting Briefing Book — OBX-319

Pre-submission briefing for OBX-319: the completed pivotal evidence, the proposed application content and format, the integrated summaries and datasets plan, and agreement on filing expectations.