Replies to post #223946 on Amarin Corp Plc (AMRN)

[Atom0aks]

Atom are U suggesting that the FDA will not include diabetics with 1 additional risk factor because the RRR is ONLY 12% ??

Yes.

Ezetimibe is approved for what I recall is even less the that .

As far as I'm aware, Ezetimibe is indicated for dyslipidemia, not CVD (as Amarin is looking for).

Its a risk / benefit analysis based on data . What the risk for including these primary prevention diabetic ....?

The FDA is not typically known to approve labels on the basis of, "what's the worse that could happen?"

[rtc110]

Kiwi...

I am not smart enough to engage in this debate, but I certainly agree with your logic regarding the question around the risk of approving for primary prevention with a 12% RRR.

Thanks

rtc

[oneragman]

Kiwi, I agree. Ezetimibe I believe has about a 6% RRR. I would say V has a better safety profile also. Factor in the ICER report and even at 12% would be cost effective for primary prevention.