Amarin Corp Plc (AMRN)

[HDGabor]

BB-

What will the FDA do with ANCHOR SPA after AACE and EAS recommend treatment of high trigs 200 + in 2018?

Nothing ... drugs approval were and will be based on proven safety and effectiveness of the drug, not on recommendation.

It will be difficult for the FDA to support rescindment for ANCHOR based on a study of a different drug and powered for a different surrogate marker....

The cited studies support the rescission ... decreased the possibility that TG is a valid marker. The valid marker (change of the marker) should be show effectiveness with any type of drug, independently from the the type of the drug and the type of the study.
- TG was reduced significantly in these studies? - YES
- CVE was reduced significantly in these studies? - NO
- TG reduction in subgroups (low TG and high TG) showed CVE reduction in these studies? - NO

After these studies TG role (in CVE reduction) became more questionable, than before ... more likely, TG isn't a valid biomarker ... so why approve anything based on TG reduction?

The mistake was the SPA agreement and isn't the rescindment ... the mistake was corrected ... kept to laws and regulations.

Best,
G