Replies to post #417752 on Amarin Corp Plc (AMRN)

[JRoon71]

TCI, great post, and great points. I have no idea if this trial would lead to any indications without an additional trial, but you are correct that the study began prior to the current FDA guidelines.

*Hopefully* Denner has a well laid-out plan for this if the results are, in fact, positive.

[Whalatane]

TCII. briefly ( maybe more later ) re P values

Regarding p values, as the number of individuals enrolled in a study (the sample size) increases, the likelihood of finding a statistically significant effect increases.

So Brave EPA may fail to achieve a P value of less then .05 with an enrollment of 150 patients ....but may be stat sig ( P less than .05 ) if they had enrolled 1500 patients. This has to do with Powering in the trial design .

The concept of statistical power is more associated with sample size, the power of the study increases with an increase in sample size. Ideally, minimum power of a study required is 80%.

Laurent knows more about this then moi so maybe he could clarify
Kiwi

[Laurent Maldague]

Very logical post. If Brave clean sweeps all three measurements - cerebral blood flow, CSF tau/amyloid ratios, and PACC cognitive scores - then that is a huge deal, no matter how you slice it.

It's also possible though that we see efficacy in some subset of those three measures (presumably cerebral blood flow would be the first to show a difference), and that's where we'll have to assess whether or not a larger outcomes trial is worth it.