Replies to post #417693 on Amarin Corp Plc (AMRN)

[TastyTheElf]

Well keep in mind size and p-value are correlated — you can have the same results with n=100 and n=1000 and p-values of .1 and .0001

[Whalatane]

N7. Size of the study is irrelevant ?

A P value is also affected by sample size and the magnitude of effect. Generally the larger the sample size, the more likely a study will find a significant relationship if one exists. As the sample size increases the impact of random error is reduced.

Kiwi

[Laurent Maldague]

Sleven, some of my thoughts on what decisions will need to be made if Brave is positive, and assuming we need a larger outcomes trial for FDA/EMA approval:

What cohort would the larger outcomes trial be run on? Looking at the two recent hot outcomes trial, CLARITY AD and TRAILBLAZER-ALZ 2, those trials were done with patients in the early stages of Alzheimer's. Would we emulate those trials, or would we stick with the cohort studied in Brave (cognitively healthy but high risk)?

Would we run the outcomes trial on Vascepa, or on the new lymph releasing formulation?

Would we use a mineral oil placebo for the larger outcomes trial (Brave used mineral oil), or is there going to be an uproar again over this issue?

Lastly, when would we launch this larger outcomes trial? It'll be costly, but a successful outcomes trial ending in 2027 or 2028 should yield enormous value in Europe, where we'd extend regulatory exclusivity into 2032. But this is only feasible if we launch the outcomes trial sometime in 2024.