Replies to post #58178 on Amarin Corp Plc (AMRN)

[HDGabor]

JL-

Amarin is not going to take an early look at the the trial. That's far too dangerous and they risk the trial results. The FDA would be the first one to bury them and call the trial a farce.

How do you mean it? One early look (@60%) exists already, agreed w FDA. What is the danger in case of additional, same type of look at different stage(s)?

Amarin doesn't need FDA's swift interpretation of the R-I results

??? I did not say this. I said:

increased p value (?) at interim(s), meanwhile stay within statistical meaning

It means, [as an example, no calculation behind it]: instead of 0.0076 p value, 0.01 will be enough @60% and the power will remain sufficient -> 22-23 eff% will be enough for early stop instead of 25-27%

Best,
G