Excellent post AVII77 - Several months Amarin referenced in the PR released probably translates into 4-5 months and the DMC decision within the 6th month time frame.
AVII, thanks for the clear explanation of the interim review process. You said, " IMPROVE-IT trial and zetia didn't get the label expansion even though the results were Stat Sig", IMPROVE-IT's RRR is 6.2%, less than 10% it's looking for. Is it still stat sig? Do you know why R-I is shooting for 15% instead of 10%?
So you believe that the 967th event may not (or may have ) have occurred. It is first necessary to scrub data to determine accuracy of events. ie someone could have gone to the emergency room with chest pain, but it may have been from indigestion. So, events must be verified. Correct?
Huh? There couldn't possible be enough time to adjudicate, analyze, and transfer data in order to have DMC review it 6 months from now if that were true - and RRR would be massively high if it took that long to reach #967, unless you meant June/July of last year, which I'm pretty sure you are not saying, as that would be a disaster for the trial (way too early).
I know you didn't see this until after you posted, but it confirms what we think - #967 is believed to have occurred and it's working it's way through the process:
IR response to @greenday regarding 967th event timing,