Replies to post #29109 on Amarin Corp Plc (AMRN)

[BioChica]

Actually, even the sponsor should not do this unless totally necessary. The FDA is a bit anal about the sponsor taking a peak!

7.2. Accessing Interim Data

As discussed above, accessing interim data by the sponsor carries many risks, not all of which may be fully appreciated by the sponsor. We recommend that sponsors contact FDA before initiating communication with the DMC regarding access to interim data from a trial likely to be an important part of a regulatory submission.

While FDA permission is not required, a discussion regarding the potential risks and implications of that action and of methods to limit the risks may contribute to informed decision making.

[BioChica]

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.

[invest2992]

DMC can also halt for efficacy. If 30% fewer deaths in Vascepa arm than placebo arm, DMC would be morally bound to stop reduce-it early. Just saying.