Amarin Corp Plc (AMRN)

[jfmcrr]

CardioMD - No - You are missing an important issue that I think a stats person made in the adcom. The lack of significant interaction between V and Primary/Secondary on hard MACE (and only p<.15 or so for 5 point MACE) means that they are NOT required to even investigate the magnitude of effects of V on MACE separately in primary and secondary groups. It was not powered to examine separately in subgroups. No interaction means the effect did not differ between groups, and that was the point the stats person made.

And hopefully this, and the riff about the strongest case being the group as a whole and that any sub-grouping dilutes the power, results in as wide a label as possible.

IIRC, the panel as a whole were talking up up how to slice and dice the label by relative results/criteria. The speaker more or less said; Everybody benefited. If the effect appears to differentiate by some measure, but remains positive across any subgroups, how do you exclude on age, biomarker levels or risk factors? Let the doctor make the decision who to trat, given the widely positive results.

That said, I'd still make an appt w/ CardioMD.