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Saturday, May 04, 2019 9:06:26 AM
I do not believe supply issues have any bearing on the EU submission one way or another. Amarin (like all companies preparing to bring a drug to market) has been planning their regulatory strategy years in advance of this. Because of the similarities in dossier content and format, US and EU are almost always submitted in tandem w/ one another. So I can’t see how they wouldn’t be prepared to meet demand in the two biggest markets in the world, seeing as they’ve been planning this for years.
I think their silence on the topic is nothing more than gamesmanship.
IMO, if Amarin does not file the EU submission by this next deadline of June 3, or at the very worst July 1, they really screwed something up.
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