Replies to post #206574 on Amarin Corp Plc (AMRN)

[Invest83838]

Cal, My Point is that

The current label is for MARINE 500 and greater trig level

When FDA ambushed AMRN at the ANCHOR SPA, they indicated that, although the ANCHOR test data looked great for trig levels between 135 and 500, they wanted to have the REDUCE IT results before granting approval

So FDA should be "good to their word" and grant 2 labels

One for the Trig level 135 and greater (ANCHOR + MARINE) - Vascepa Only

One for the REDUCE IT test Vascepa & statin for CVD

[KCSVEN]

Label will have statins since that was RI population but for Amarin to run a study without statins would have been almost impossible.

With that said, many people stop taking statins for side effecst, and a reasonable doctor approach would be to try Vascepa without statins at that point, common sense would say it would help without a statin, which is different than an FDA study and label.

So I think it will eventually have many people taking it that are not taking statins

[oneragman]

Cal, Repatha is approved for use with or without a statin. They did not have a 3rd arm in the trial. Don't be surprised when the label does not require V to be used with a statin.