Tuesday, August 18, 2015 12:49:33 PM
BB- ??? Who gave the NCE to Amarin? Not the Judge (as you wrote). Amarin does not have an NCE (legally). 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
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.
FDA not updating OB tells us there's something else 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
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