Amarin Corp Plc (AMRN)

[BiotechWill]

SMACKDOWN BIOB time -

So I had a conversation just now to confirm this, and despite me getting trapped into your ramblings yesterday and arguing a separate point about NME/NCE after 502b filing -

The document you are actually referencing has been known about for awhile, and is correct entirely?

Why? Because it references the NDA and the review process, where Vascepa aka AMR101 was granted a standard review as a... GASP... NEW ESTER--- which for CDER purposes, is not listed as a NME.

To further your education:

Priority Review - Significant improvement compared to marketed products in the treatment, diagnosis, or prevention of a disease.

Standard Review - The drug appears to have therapeutic qualities similar to those of one or more already marketed drugs.

Chemical Types:
1 - New molecular entity
2 - New ester, new salt, or other noncovalent derivative
3 - New formulation
4 - New combination
5 - New manufacturer
6 - New indication (Beginning in 1994, Type 6 NDAs were tracked as efficacy supplements)
7 - Drug already marketed, but without an approved NDA

As Vascepa is a NEW ESTER, aka an ethyl ester of eicosapentaenoic acid, it was granted standard review, new ester status in terms of CDER listing.

502b status, per the docs I posted yesterday, has not been decided.

Now shh.