Amarin Corp Plc (AMRN)

[HDGabor]

b-

It's my fault as drrc1949 pointed correctly I am not always crystal clear, understandable. Let me approach it differently.

We agree: FDA did not notify Amarin within a reason able time, it could be a basis of a suit (I never said anything else reg. the timing)

We did not agree: FDA breach or not the SPA.

FDA did not breach the SPA as they have legal authority to rescind it if they have a reason. The question is that the reason is good or not.

I hope we could agree, except the LDL-C, none of the lipids are validated as surrogate endpoint and this is the key point.

FDA approved lipid-altering drugs based on their assumptions that favorable changes in the lipid profile would translate into a benefit on clinical outcomes. Based on other studies they feel that this assumption is weaker now (at the time of the rescission) and required validation. They did not say TG could not be a validated surrogate endpoint, they just do not know yet.

According to Amarin PR: ”However, FDA concluded that in its view the totality of scientific data and information, including its reevaluation and improved understanding of the relevant scientific knowledge since the ANCHOR trial began, does not support use of decreases in triglycerides as a validated surrogate for cardiovascular risk reduction in the proposed patient population.”

or with other words it was not a validated endpoint and still not.

The basis of the whole "debate" was that Amarin "has to" appeal / sue or not.

I said not, due to the reason above and because of the duration of the appeal / legal process (ruling could be around mid-2017 only).