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Re: Whalatane post# 190404

Monday, 05/06/2019 2:59:07 PM

Monday, May 06, 2019 2:59:07 PM

Post# of 430138
Kiwi -

I don't accept your idea that the FDA is negotiating



That's ok, you don't need to accept my idea, but you should certainly accept Thero's QUOTE, from last week:

The sNDA we submitted seeks a label for cardiovascular risk reduction consistent with the REDUCE-IT results. The details of such a label will be subject to negotiation between the FDA and Amarin. It would be counterproductive to such interactions with the FDA for us to publicly speculate on labeled details at this time.



Welcome to the real world, Kiwi.

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