Replies to post #56811 on Amarin Corp Plc (AMRN)

[HDGabor]

BB-

Amarin still has NCE until at least 7-26-2017 ... Judge Moss didn't rule the FDA must assign 5 yrs, he vacated the 3 year NME.

??? Who gave the NCE to Amarin? Not the Judge (as you wrote). Amarin does not have an NCE (legally).

FDA not updating OB tells us there's something else going on.

FDA's process (determination of the status of V), "consistent with this Opinion" is going on.

btw: the "theory" was "Maybe ... maybe not", I did not say it is sure.

Could you please refer to the Law? (Basis of NCE for REDUCE-IT.)

Best,
G

[louieblouie]

If FDA holds exclusivity through R-It - and the final study on R-it isnt done until 2019 - then the 5 year period has come and gone - so how does AMRN determine when to file for the additional 30 months when the time has come and gone - if there are no regulations addressing that?