Amarin filed a 505 b 2 intial application. NCE can be requested in this application, but it is tied to patents. Newest substance patent in OB form fills this requirement. Thus we will be granted NCE on next update. They would have granted 3 NME if the FDA didn't intend to grant NCE. That's it...show's over.
Just my humble read into all the documents.
Williams.... so does that mean it'll be part of the February update, which would = NCE listing for this coming orange book update, or does it mean it'll be part of the March update, which would be in the April orange book?
Williams, On page 38 of the "Other Reviews" PDF I am pasting the following:
14) Which of the following patent certifications does the application contain? (Check all that
apply and identify the patents to which each type of certification was made, as appropriate.)
X No patent certifications are required (e.g., because application is based solely on
published literature that does not cite a specific innovator product)
I may be confused but I still cant find the section or references where you are saying that AMRN's patent was required for NCE. Am I referring to the wrong section?
Williams, were are you seeing that this is tied to patents and that newest substance patent in OB fills the requirement? Can you elaborate or show page #'s from the specific PDF's to show this?
I think Anchor will be a separate 505 b 2, and new PDUFA. Anchor data could be added to label though, as rumored before approval. This is looking very good. Amarin f'd up by not proving the Pharmacology between Japan's Epadel and Vascepa, this whole application almost got submarine late 2011. That's just history now. A no to NCE would have been submitted, YES needed patent wording for NCE 5 yr with the 505 b 2. It appears we have that booked now the the 9 we have in the OB two of which are product claims.
Anchor will come before the end of 2013 and sNDA 505 b 2 for AMR 102 may also come this year. That's a shot across the bow of BP's ship.