Replies to post #110527 on Amarin Corp Plc (AMRN)

[fsulevine]

Raf - See my previous post where I tried to explain my thoughts on what they are looking for regarding safety.

[IslandOfMisfitToys]

The entire point of this discussion started when someone here said that what if the 80% IA was added as a result of the safety committee seeing the data BEFORE the 60% analysis, and possibly giving a wink to Amarin?

They could see more deaths on one side, because deaths are relevant to safety. Usually, the presence of side effects is actually correlated somewhat with efficacy -- I don't think that is relevant here, but often it is -- drugs that do nothing often have a very clean safety profile. The endpoints in this trial are also obviously adverse events that could be signals for safety problems.

The DMC signaled nothing to AMRN. The DMC had no involvement in discussions with the FDA. The DMC sends back continuation recs to AMRN after their reviews. That's the sum total of the "winks" AMRN has to date from the DMC.

[oneragman]

Raf,
Doing this one the phone, so reponse will be brief. I was not implying a "wink". I laid out to me a plausible scenario where the DMC asked for an additional look. In my business, I have seen it all and run scenarios as to reasons why things are unfolding as they are and everything that can go wrong. Ever hear of Captain Phillips? Pirate's messing up my shipment was the last time I was caught off guard.