Avid Bioservices Inc (CDMO)

[pphmtoolong]

DMC guidance from the FDA. To answer my own question:

In many cases, the DMC receives reports in two parts: an "open" section, which presents data only in aggregate and focuses on trial conduct issues such as accrual and dropout rates, timeliness of data submission, eligibility rates and reasons for ineligibility; and a "closed" section, in which the comparative outcome data are presented. The open section of these reports is usually provided to sponsors, who may convey any relevant information in these reports to investigators, IRBs, and other interested parties, as the data presented in the "open" section are not likely to bias the future conduct of the trial and are often important for improving trial management.

So, I suppose the issue regarding DMC interim results is what is in the open section vs. what is in the closed section. Maybe Peregrine can share with us what our DMC instructions are in this area.

GLTA, Paul