Replies to post #5087 on Amarin Corp Plc (AMRN)

[Biobillionair]

Assuming sNDA filed at the FDA was BASF, timing would coincide with both Chemport and BASF announcements in December, what excuse would Amarin have for not filing an 8-K in the 4 business day window?

FDA APROVAL of an API supplier is no doubt a must 8-K.

Thoughts?

[bravo33]

Biobillionair - are you sure exclusivity determination doesn't tie back to the original drug filing for Vascepa - as opposed to the sNDA review acceptance for ANCHOR in 4/2013? If it does tie back to the original review for Vascepa MARINE then that pre-dates the 11/2012 initiation. BTW - I HOPE you're correct in a big way! Thx.

[funnygi2]

Bio,

Does that footnote imply approval of NCE at the time of approval of NDA or at time of acceptance of NDA into the new program? It says approval.

Also it distinctly says the new policy applies to NME NDA's. Do sNDA's come under the same policy??