Amarin Corp Plc (AMRN)

[HDGabor]

r-

Lastly does anyone know when Hikma submitted this to the FDA?

In the first half of 2014 but following the May 28, 2015 District of Columbia court order setting aside FDA’s denial of NCE exclusivity for Vascepa, FDA notified the ANDA filers that FDA had changed the status of their ANDAs to submitted, but no longer accepted. … It was (re)submitted in September / October 2016.

If very recently (after trial verdict) then it means they don't fully comprehend the idea that Amarin will not market in the U.S. and that they intend to vigorously defend in the upcoming appeal.

Apotex submitted a new / full ANDA recently. (They submitted it 2016 also but w/o a complete PIV notice).

Best,
G