Amarin Corp Plc (AMRN)

[HDGabor]

z- "Agree" …. except:

The generics had the opportunity to file an ANDA in 2012 after the FDA had approved Marine

The generic did not know in 2012 (till February 21, 2014) that they could submit or not since FDA did not issue NME / NCE determination.

but they chose to wait until 2016

Nope. ANDAs were filed 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

but they chose to wait until 2016

They "chose" to wait till September/October 2016 … chose to "wait" two months. The earliest possible submission was July 2016 (4th anniversary of approval).

Best,
G