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Biobillionair

06/01/20 11:53 AM

#277350 RE: Chris2125 #277347

Looks like Amarin reads my posts and emails....

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=155919297

Just saying....

BB
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rosemountbomber

06/01/20 11:53 AM

#277351 RE: Chris2125 #277347

Chris it is possible but EU approval they indicate Q3 2020 and appeal decision can go as far out as Q1 2021. Clock starts on approval in Europe and time is money.

If there is a way to not optimize a business plan ( I am being kind) Amarin management will find it.
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Biobillionair

06/01/20 12:02 PM

#277354 RE: Chris2125 #277347

Who's the best "hybrid" European partner? Might be AZN...
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HDGabor

06/01/20 2:42 PM

#277383 RE: Chris2125 #277347

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