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Posted On: 10/14/2020 5:53:13 PM
Post# of 148899
I agree it's encouraging to hear him say that. According to this guide from fda.gov, having the FDA work with the DMC is not unprecedented.
https://www.fda.gov/media/75398/download
That said, it would be nice to have this confirmed by Cytodyn (NP) rather than have to rely on a presentation by an unaffiliated Dr.
https://www.fda.gov/media/75398/download
Quote:
7.2.2. FDA Interaction with DMCs
In rare cases, we may wish to interact with a DMC of an ongoing trial to ensure that specific issues of urgent concern to FDA are fully considered by the DMC or to address questions to the DMC regarding the consistency of the safety data in the ongoing trial to that in the earlier trials, to optimize regulatory decision making.
That said, it would be nice to have this confirmed by Cytodyn (NP) rather than have to rely on a presentation by an unaffiliated Dr.
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