Replies to post #112479 on Amarin Corp Plc (AMRN)

[rosemountbomber]

Have to agree with you STS that there is no way the trial would not have been stopped at 80% with those RRR numbers

[HDGabor]

sts-

3.5/5.9= 41%

Let me help ... V arm/placebo arm = RRR ... 41% is the correct number (not (51%)

44% RRR - can't believe the trial wasn't halted at 80% IA with a PE RRR like that regardless of SEs when the trial is designed to show 15% RRR

(a) design of the trial isn't equal expectation and definitely isn't with doable
(b) it isn't about the PE only ... SEs, especially SE(s) with p<0.002, could matter more than the PE itself. Furthermore, the guidance from Amarin was B&W (plus some grey): PE is the gatekeeper for SEs analysis only, isn't enough for stop ... and the grey:

I believe your interpretation is DMC saying "you're wasting money continuing the trial for SEs you're never going to get stat sig data for, it's futile to keep going" - but from what we know R-IT rules for DMC do not contain any futility analysis.

Futility analysis is about the objectives ... in case of R-IT it is the PE only. I think the "unethical to continue" was used due to a reason ... just like of what JT said: "no formal futility analysis". So yes, my interpretation is DMC concluded (did not say to Amarin): "Despite PE hit the required p value and SEs are robust and consistent, continuing the trial one / some / all SEs, that was / were not stat. sig. at IA, more likely will / could be at final" ... maybe one / some / more of them will have low enough p-value (0.002) for "Indication and usage" (label).

Amarin should not worry about patients they should worry about the strongest R-IT result.

Best,
G