Amarin Corp Plc (AMRN)

[Atom0aks]

AtomO..

Whether or not the primary cohort showed significance is only part of the story...The R-I trial was not powered to detect significance in the primary cohort...The reality is that the primary cohort although being a smaller group than the secondary showed the same RRRs as the secondary...Its just there were fewer of them...And that is the reason the primary cohort should be included (and probably will be ) on the label..

The point was Vascepa was not less effective than the secondary group..the RRRs were basically the same...

":>) JL

Right, amarin is trying to piggyback results from a nonsignificant, underpowered population onto a larger, significant population which would markedly expand the target population. That's not the way labels should be approved. And I think many other adcom members thought the same. It's unscientific and might encourage other pharmaceutical companies to be similarly deceptive. The right way to do it, as was pointed out by the adcom would be to do an adequately powered primary prevention trial for however long Dr. Bhatt thinks it would take to see the divergence that may or may not have been present in the reduce-it study.