Replies to post #85662 on Amarin Corp Plc (AMRN)

[HDGabor]

K-

??? I never said it is about efficacy (RRR / PE) only and it is exactly the same that I quoted: #85654

Of course since you and JL know what the key secondary end points and sub groups are ...you have no problem determining the robustness and consistency of the data required

??? Please quote it from JL or from me ... We never said it and it is the reason why we think that the probability is 70/75% (and not 100%) of stop. Both of us think if the study will be continued it will be due to SEs.

Do you or Gabor have a problem with this definition of Power in clinical trials ?

No we don't have, but it looks like you have. Just a reminder: you said

The big criticism I can see here would be the power of the study to that point in time ... only about 23,000 patient yrs .

The power isn't affected by pt yrs. To make it easy to understand by you:

a.) @final in 2017

Projected to provide 90% power to detect 15% relative risk reduction (>95% power to detect >20% relative risk reduction)

The pt yrs will be the same but the power will be higher at bigger efficacy

b.) if the study will run one more year to reach final (app. 1,612 events) in 2018 (to avoid any doubt: it is not likely / possible) with the same relative risk reduction (15%) the power will be 90%, despite additional app. 7,000 pt yrs

The power is determined by size, event number and "separation" independently from the time (pt yrs), how long it takes.

Best,
G