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exwannabe

01/17/22 1:31 PM

#435761 RE: greenJack #435759

Was Amarin involved with 4 regulators at that time? I do believe that’s what makes NWBO a lot harder to control.


Nope, not 4 RAs.

11.

And over 8000 patients.

EDIT: Also fairly complex endpoints. Yet they needed only a couple weeks post data lock to PR the win and a couple months to present and publish in the top forum for heart issues.

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ilovetech

01/17/22 1:40 PM

#435771 RE: greenJack #435759

Green, without getting into the weeds here, although Amarin's trials were Internationally conducted, I don't know why it's drug had to go through an approval process in the States, and a submission in Europe afterwards. What's interesting is that Vascepa was so unexpectedly impressive on biomarkers when everything else failed, an ADCOM was convened, which ended up forcing Amarin to conduct an additional 6 year outcome study. It's been an absolute sh*t show of cataclysmic events to the present day.

ILT