G- Watson appeal can't hold OB from being updated...if appeal was accepted Amarin still has NCE until at least 7-26-2017 or the appeal is ruled on vacating Judge Moss decision. Judge Moss didn't rule the FDA must assign 5 yrs, he vacated the 3 year NME. FDA not updating OB tells us there's something else going on. Until you can explain this reason your theory is legally flawed.
The 505b1 for Vascepa isn't just claiming a new treatment population, it's claiming a new treatment for Heart Disease.
I expect Trig and reduction of cardiovascular disease to be two separate applications... FDA will hold exclusivity until REDUCE-IT.
I also expect the FDA to clarify this soon through a letter to Amarin.
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