Amarin Corp Plc (AMRN)

[HDGabor]

I agree with the FDA: the science was changed since 2008. … regarding the target population …

Assumption: something taken for granted; a supposition: a correct assumption.
Synonyms: presupposition; hypothesis, conjecture, guess, postulate, theory.

„With rare exception, FDA has historically considered granting approval for lipid-altering drugs based on favorable changes in the lipid profile, with the assumption that these changes would translate into a benefit on clinical outcomes.” –from FDA’s BD

“Recent clinical trials and meta-analyses have failed to confirm definitive cardiovascular benefit with EPA and DHA supplementation, however.” –from FDA’s BD

“Although treatment effects of non-statin lipid-altering therapy have been suggested in several trials in variably defined high TG/low HDL-C subgroups, the hypothesis has not yet been tested that a patient population can be prospectively identified who will benefit from such therapy.” –from FDA’s BD