Amarin Corp Plc (AMRN)

[HDGabor]

Do not judging what you say, just do not understand the difference between ANCHOR and "to market Vascepa for Trgs >200mg/dl. but to clearly state that there is no proof as yet that it lowers CVE's." as FDA - and not Amarin - said during the AdCom:

"Vascepa 4 grams per day is indicated as an adjunct to diet and in combination with a statin to reduce triglycerides, non-HDL, Apo B, LDL, total cholesterol, and VLDL in adult patients with mixed dyslipidemia and coronary heart disease or coronary heart disease risk-equivalent, as defined on the slide."

"Although the indication strictly speaks to reduction in lipoprotein levels and improvement in numbers, this indication for this population certainly implies that one should expect cardiovascular benefit from treatment."

For "All Agency wanted was a compromise," they did not have to rescind the SPA. Simple approve it with a label:

"VASCEPA is an ethyl ester of eicosapentaenoic acid (EPA) indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with high(= 200 mg/dL and and <500 mg/dL).
Limitations of Use:
•The effect of VASCEPA on cardiovascular mortality and morbidity and reduction of the risk for cardiovascular diseasehas not been determined."

I see one reason only to rescined the SPA: they do not have to decide on sNDA till the appeal is ongoing (and it was obvious that Amarin will appeal.)

I just want to understand what you are saying.