DSMB Meeting Minutes (OBX319-301)

Document ID: TMF-007
Version: 1.0
Change History: 1.0 — Initial issue.
Standard(s): ICH E6(R3)

DSMB Meeting Minutes — OBX319-301

Minutes of the independent DSMB reviews for OBX319-301: attendees, data reviewed (by treatment group, unblinded to the DSMB), the benefit-risk discussion, and the recommendation to the sponsor (continue/modify/stop). FDA DMC guidance; ICH E6(R3).