Amarin Corp Plc (AMRN)

[HDGabor]

(I think) The trial will be stopped based on interim analysis, however the interim analysis will be in 2016 (not in 2015).

Safety side: it's fine, the DMC review the safety data on a quarterly basis and they gave a the thumbs-up every time

Efficacy: "is blind to that committee [DMC] and to ourselves [Amarin], other than whatever they [DMC] might interpret based upon the safety." (Q3's CC)

So interim analysis will be done at / after 967th event, and it is expected (by me) in Jan/ Feb 2016, as:
- after the event, the statisticians will prepare the analysis (meanwhile DMC & AMRN are still blinded).
- 2 months after the 967th event the analysis will be delivered to the DMC, meanwhile AMRN is still blinded (Note: 2 months is just my guess, if anybody has a more exact knowledge about the possible duration of the analysis let me/us know)
- if the result meet with the stopping rule, the DMC will recommend the early stop to AMRN (I guess it is still blinded to AMRN)
- AMRN will decide to accept the recommendation or not. If yes, the study will be unblided to AMRN also.

Based on that the "100% of the targeted events currently anticipated to occur by the end of 2017" (Q4) I expect 23-31% eff. and it will be enough for early stop. >19.5% required for p-value <0.001 and/or 25% for 99% power ((c) data by Biwatch)