Amarin Corp Plc (AMRN)

[HDGabor]

c-

The principal concern / target (first priority) for patients with severe hypertriglyceridemia, levels of TG 500 or greater (MARINE), is that to get their triglycerides down in an attempt to avoid acute pancreatitis.
An event driven study where pancreatitis is the endpoint would be tough to do, not possible, TG reduction is the correct basis for efficacy / approval.

The only reason to treat patients with TG below 500 is to prevent CVE (a clinical outcome). The science of TG (as a marker of CVE reduction) is mixed, TG reduction (especially as a stand alone marker) wasn't (and won't be by R-IT) confirmed as has a 1:1 relation with CVE reduction.
The FDA (requesting R-IT result instead of ANCHOR), did not set the bar so high, they set the bar on the correct / right level ... to confirm clinical effectiveness clinical outcome is necessary. V - as we think - could be effective against CVE, but it should be proven for approval, promise isn't enough.
Please note: To consider TG as a valid marker (TG reduction will be resulted in CVE reduction) it should be detected with different class / type of drug, since in this case it does not depend on the MOA / etc. of the drug ... TG is a real marker. Until that it is (more likely) a symptom only.

I did not see any sign that it was personal against Amarin or requested / pressured by any entity (commercial or governmental) ... Amarin was at the wrong place at the wrong time. Please note: if they were to sign / get ANCHOR SPA in 2012/2013 they wouldn't get it.

Amarin "forced" the ANCHOR till it makes sense (till OND level), but let go it finally.
I am wondering anybody think seriously, that Amarin / management, which sued the FDA in 2, first in class cases (and won) should go further with SPA appeal ... the case wasn't / isn't winnable, they let it go due to a good reason (and it wasn't something else other tan as I said above).

Best,
G