Replies to post #163595 on Amarin Corp Plc (AMRN)

[Anonymous Fish]

This may be of use to you:

https://www.sec.gov/Archives/edgar/data/897448/000119312515150702/d916310d8k.htm

"In prior dialogue with Amarin, FDA urged Amarin to complete the ongoing REDUCE-IT (Reduction of Cardiovascular Events with EPA—Intervention Trial) cardiovascular outcomes study. Consistent with this position, FDA stated to Amarin in the CRL that FDA anticipates that the final results from the REDUCE-IT trial could be submitted to satisfy the FDA’s uncertainty regarding the benefits of drug-induced changes in lipid/lipoprotein parameters on cardiovascular risk in the ANCHOR population. The CRL has no effect on the SPA agreement for the REDUCE-IT study or the anticipated timing for results from the REDUCE-IT study."

I'll see if I can dig up the actual CRL letter....

[sts66]

Is it possible that we are not submitting a sNDA? But rather a response to a CRL from a previous sNDA (ANCHOR)?

No. ANCHOR is dead. CRL said AMRN had 1 yr to respond with the requested additional info, and if it was not received in time the sNDA would be considered withdrawn (AMNR may have had option to ask for short extension, but they didn't, no point). I have the CRL PDF stashed somewhere, but don't need to find it and look it up - that 1 yr timeline stuck out like a sore thumb, impossible to forget.

[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.