Replies to post #99651 on Amarin Corp Plc (AMRN)

[HDGabor]

JL-

The Co does not have "any, real" influence on the process.

1.) Start of the IA process: I do not know, how / who start the process exactly ... it is initiated by the Co or somebody else ... but let's assume by the Co when they know:
- enough events (adjudicated occurrence) AND enough occurrence in the adjudication process for required events (it was the case at 1st IA) or
- enough events for required events (it takes more time, occur at a later date)
2.) site visit by patients - it will take more or less the same time as at 1st IA
3.) data checking - it will be significantly shorter as 16k vs 36k (at 1st IA) data (site visits)
4.) Statistical analysis and DMC - it will take more or less the same time as at 1st IA

Co could "manage" 1 above only, but not the 2-4.

In case of stop: it will be announced, but the process above will be repeated
In case of cont.: the process above will be repeated after final / last event

Best,
G

[chas1232123]

JL - I agree that there is plenty of uncertainty about how soon Amarin would prefer to have their interim analysis. They're as eager as we all are to get the V label expansion ASAP, but more events mean more robust results, so they may very well feel like dragging their feet. For my guess, I assumed they will start working on their IA prep in Feb and March if they believe event 1290 probably occurred in about late January, even if they don't announce it until they get more certain data at the end of the quarter. That may be a stretch, and it is entirely possible they'll wait until the end of the quarter to start work. Of course, it's all guess work from limited information, and I wouldn't recommend anyone to bet anything they weren't very prepared to lose on specific timing. With the extra thousand subjects, plus an extra 185, and enhanced recruiting for many of them, they may feel confident without extra delay into the 80% IA, even with the continue at 60%. 80 is a lot more than 60, especially if the efficacy demonstrated by RI increases with time, as we expect. Time will tell.