Replies to post #422311 on Amarin Corp Plc (AMRN)

[the_kube]

The following is from the Brave study. Based on this, does this mean study’s selected participants are less likely to have any positive response to icosapent ethyl?

“The proposed study is a proof-of-concept, randomized, placebo-controlled, double-blind, parallel-group clinical trial assessing the efficacy of 18 months of icosapent ethyl (IPE) therapy on magnetic resonance imaging (MRI), cerebrospinal fluid (CSF), and cognitive biomarkers for AD in 150 cognitively-healthy Veterans ages 50-70 years with increased risk for developing AD due to parental history of the disease and increased prevalence of apolipoprotein E4 (APOE4) allele.”

[JRoon71]

Zip, not necessarily. BRAVE had nothing to do with A/D outcomes (there were some secondary cognitive measures, but I doubt those showed much). The study was purely about bio markers. And it's entirely possible that the study simply wasn't long enough/powerful enough to achieve its outcomes.

This is the weakness of scientific study. It can only produce what you measure. So for something like BRAVE, while it's entirely possible (more likely than not) that EPA does reduce the incidence of A/D to some degree, a study like BRAVE could come to a null conclusion.

I am just hoping that there is ENOUGH evidence (even if not statistically significant) to continue pursuing EPA as an A/D solution. Because realistically, BRAVE was not going to result in a new indication, but rather lead to additional, more extensive trials.

[north40000]

It appears to me that the FDA could approve the use of Vascepa to treat AD/dementia by way of its statutory authority to approve the use of medications on a “right to try” basis, in light of the biomarkers evidence supporting such use already extant that you and kube post. Confirmatory trials confirming such use would then be initiated.