Amarin Corp Plc (AMRN)

[AVII77]

As noted above, this is verbatim from FDA and also codified in federal regulations, so really not subject to debate. Or in other words, checkmate. If you’re still confused, I suggest you immerse yourself in 21 CFR 314, you’d learn a lot.

OldYella, I saw your post yesterday on my phone and thought it great we finally have a REAL regulatory expert here. I'm sorry about the welcome you've received. Folks are a bit edgy. I am a self-taught amateur when it comes to Regulatory Science (and bio-stats, clinical trials and EBM) but I recognized your post as accurate and have no reason to doubt your credentials.

When I saw your post I wanted to ask your opinion on something (point 1 below). The recent <cough> discussion raised another point we could use your input on (point 2 below).

1. Buried in the NEJM published protocol is a comment about the date of the pre-sNDA meeting. "As discussed and agreed with the Food and Drug Administration (FDA) in relation to a pre-sNDA meeting on 07 March 2018, this SAP Addendum has been developed ...."

So, I wonder if you have any comments on the date of that meeting. All I know is that it should be at least 2 months prior to submission (which it is). Do you have any comments or insight to offer on a pre-sNDA meeting ~12 months prior to submission?

But the recent debate brought up another point.

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

The CRL announcement said:

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.

If that is the case the relevant PDUFA clock would be for "Resubmitted Efficacy Supplements" which is 2 months (Class 1) or 6 months (Class 2) from the filing date (which is, as you correctly note, 2 months after submission). That would be consistent with managements guidance of approval in Q4 2019 (otherwise, as you note, it is 12 months for standard review from the date they send it in)

Anyway, I would like to hear your views on those 2 points.

And, a general question for the board: I seem to recall actually seeing the ANCHOR CRL posted. Did that become public due to a lawsuit or the 1st Amendment case? Or am I just miss-remembering?