Replies to post #31138 on Amarin Corp Plc (AMRN)

[HDGabor]

SPAs are different:

=500 mg/dL (MARINE): It’s always approved based on surrogate endpoints, since „It's hard to imagine an event-driven pancreatitis trial for super-high triglycerides.” (Dr.Hiatt / AdCom)

=200 mg/dL and <500 mg/dL (ANCHOR & REDUCE-IT): Both evaluate the same high risk patient population, however ANCHOR was to improve atherosclerotic markers, including triglycerides, non-HDL-C, Apo B, and hsCRP without having a detrimental effect on LDL cholesterol (surrogate endpoints), meanwhile REDUCE-IT is to demonstrate Vascepa efficacy to reduce cardiovascular events. It is an event-driven trial.

FDA rescinded the ANCHOR’s SPA as improvement of these markers is not enough to determine the efficiency.

I do not say that the FDA will not try to null the R-IT trial, however they could not ignore / null the result since it’s events.

[sts66]

C'mon, we all know ANCHOR was torpedoed because AMRN went for CV risk reduction on the label, reached to far - if they hadn't done that, or compromised when offered, they wouldn't be in the position they are now. I've said it before and I'll say it again - who would have bought stock or held it through the AC if they knew what label AMRN was actually seeking? NOT ME!