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Re: jessellivermore post# 193722

Tuesday, 05/28/2019 1:23:19 PM

Tuesday, May 28, 2019 1:23:19 PM

Post# of 429503
JL, would this scenario I posted earlier this morning spoil those upcoming dialogues with Chen? Perhaps the dialogues would simply be cancelled; alternatively, Chen might have even more questions and subjects to talk about??:

"Did your evaluation allow for a PR from Amarin anytime yet today, or a communication from FDA to Amarin that amounts to neither a Priority or Standard review time? A "transaction", BB, could amount to a label negotiation that is final, or nearly so, inasmuch such negotiations may have started in early April shortly after FDA received the sNDA? Perhaps FDA is treating the sNDA as satisfying the Anchor trial outcome. What then?

Apply the above within the confines of the 74 day rule as well. What then?"
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