Replies to post #224319 on Amarin Corp Plc (AMRN)

[Atom0aks]

The concern about primary prevention possibly being omitted from the Vascepa label is unfounded. All SPA requirements have been met, and there is no reason to expect this SPA to be rescinded.

Not worried about rescission. See here (hyperlink).

Note that, as Prof Bhatt mentioned in his recent video, primary prevention subgroup had 2 year delay before benefits kicked in, vs about 1 year for secondary prevention. Adjusting for the trial underestimation of RRR due to startup effect would increase the primary prevention RRR from 12% to about 20% (factor of 4.9/(4.9-2)). Secondary prevention RRR was also underestimated, but not by as much. And, as Pharmacydude pointed out the other day, RRR of 6% was approved and is in wide use for Ezetrol.

We're in good shape.

It wasn't approved. See here (hyperlink).