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Biobillionair

05/20/19 8:09 PM

#192455 RE: KevGee59 #192451

Kev- No confusion here, plain and simple...Amarin is waiting for EU to decide speed of review. Amarin knows this will happen before end of 2019...but they don’t know if tomorrow or December. When EU decides Amarin sells Europe based on speed of view. This is the ONLY explanation and I’ve thought the sh!t out of this.

JMO
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OldYeller187

05/20/19 9:09 PM

#192467 RE: KevGee59 #192451

Yeah I’m as baffled as everyone else. Similar to Canada, the submission package to EU would be heavily leveraged from the US submission. It’s very common for companies to submit simultaneously in all these regions (ie US, CA, EU) b/c of the common dossier format they share.

We submitted very quickly in Canada, but are taking our time w/ EU for some reason. Dunno why.
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sts66

05/21/19 3:37 PM

#192605 RE: KevGee59 #192451

No confusion from where I sit - we discussed this a week or two ago - a couple co-joined reasons to delay filing in the EU: Exclusivity starts upon marketing approval, but AMRN will be supply constrained in the US market once sales take off - no reason to waste a year of exclusivity in the EU because API suppliers aren't ready to greatly increase production. Recall the statement JT made about several suppliers trying and failing to produce API because it's not an easy process.