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Re: sts66 post# 10908

Friday, 07/19/2013 4:28:27 PM

Friday, July 19, 2013 4:28:27 PM

Post# of 426582
Nobody has a clue.

My only guess is since NCE is supposed to require an Adcom and there was not one. I think originally the lawsuits over NCE created new guidelines which were not approved until May 2013 and AMRN is the first major drug caught up in NCE decision and with Anchor Adcom FDA probably said, let's wait until Adcom and discuss at Adcom.

Will be interested to see if Adcom mention NCE at all. If not then maybe they want Anchor approval to use as backup when GSK says Lovaza has same active ingredient and they can say, well if it did, it would have had same effect in Anchor population but you are not approved for that an they are.

Otherwise, no idea.
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