Also, if for good reason the FDA may take a peak. But not likely, but possible with the legal SNAFU, who knows, with Amarin they opened a can of worms, doing things they have never done before.
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.
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