Amarin Corp Plc (AMRN)

[OldYeller187]

Hi AVII77,

Thanks for the warm welcome, I appreciate it. There are a ton of experts here in the scientific realm, I was just wanting to give back by providing some input from a regulatory perspective; it seems timely, especially as we move towards the regulatory submissions.

Good question regarding the timing of the pre-sNDA meeting, unfortunately not sure I have a great answer there. I have typically seen these meetings happen ~3.5-4 months in advance of submission date, not a full year or so ahead. I'm by no means an expert on Amarin, and their whole backstory here, I just became an investor back in early October. I'll see what else I can learn regarding the pre-sNDA meeting held on 3/7/18, wasn't even aware it had happened.

As for your other question, everything I have seen, indicates an sNDA will be filed. This would be needed for expanded label. That said, a separate submission containing R-IT results could also be filed to the ANCHOR sNDA, or it could just be submitted under the upcoming sNDA, and the ANCHOR sNDA could cross reference it.