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Re: Chris2125 post# 277347

Monday, 06/01/2020 2:42:59 PM

Monday, June 01, 2020 2:42:59 PM

Post# of 427604
C- (&rosemountbomber / 277352)

Ruling expected in Q4 2020 or Q1 2021: WHAT HAPPENED TO POSSIBLY first week of September ruling???

Nothing. Ruling had not been expected as first week of September ever … it was about the oral argument (first week of "every" month is a typical timing of OAs.)

? Evaluating whether to launch in EU directly, via a partner or in a hybrid form with decision targeted for Q3 2020: IS EUROPE BEING SLOW PLAYED TO HAVE A US COURT RULING FIRST BEFORE MAKING THIS DECISION?

r-

EU approval they indicate Q3 2020

Meanwhile Amarin communication about EU approval was changed (Approval [by EU] vs recommendation of approval [by EMA] near end of 2020) no sign of "slow play" (yet). Q3 2020 had not been expected as approval ever.

The first sign / clue about "slow play" could come by end of June … Amarin could request extension of time (to reply to 120 Days letter).

Second: by end of July … if icosapent will not be in the agenda (List of Outstanding Issues or Opinion) it will mean they did not answer before end of May (please: note usual, 3-months deadline is end of June) … LoOI (or Opinion) could come by end of September as the earliest … and approval by late November / early December

As of today: the process is ongoing as normal,

Best,
G

Disclosure: I wrote this post myself, and it expresses my own opinions (IMHO). I am not receiving compensation for it.

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