If you read the FDA rule book, it is obvious that an NCE is awarded with a drug approval. There is no prior
art for Mixed Dyslipidemia (Anchor indication) The sNDA will shortly be filed and according to the SPA, (Special Protocall Assessment) Vascepa will be approved in Q3-4 and NCE will be awarded. Since Lovaza
is not approved for this indication, ie no prior art, FDA Legal team can award NCE and not face a law suit from GSK.
Sentiment: Strong Buy
I'm long here with a good amount of shares.
I agree with your comments on prior art for patent approval.
NCE however is a whole nuther ball of wax. Basically AMRN has to prove that their are no other active moieties already addressed as a chemical entity in the same field. It is the same argument that has been hashed a thousand times and I do believe that they receive it according to Dr. Goldenberg's thesis
"The FDA considers Vascepa to be a new chemical entity. It contains only EPA but not DHA, and it does not contain any appended portions of both EPA and DHA that cause them to be an ester, salt, or other non-covalent derivative. Therefore, its active moiety has not been previously approved by the FDA in any other application submitted under Section 505(b) of the Federal Food, Drug, and Cosmetic Act."
I also agree that long term it's all about the patents and not about NCE. Short term however it will matter. Just my crazy thoughts.
If nce was approved on anchor indication, Amarin should/would know that! It would be material information, and if they withheld that information, they would go to jail. If I as well as other investors were told that nce would come after snda, many would have sold their positions months ago. If Joe knows this! And didn't share, he's in trouble
Your logic makes perfect sense, but why would the company continue to act as though they expect a decision on Vascepa NCE based on the marine trial? Why wouldn't they just come out and say it wil;l be determined with anchor/ Could it be that when certain anchor patents get approval, then Vascepa could get NCE? The companys actions just don't align with this theory.
Sentiment: Strong Buy
Anchor approval is looking like December. So you are saying no NCE decision before January or February of NEXT year? lol...this is hilarious. Also means no chance of a buyout before then either.
I did not check the FDA rule book, but I have been thinking this all along. They asked for more (Anchor) and probably won't award NCE until they get what what they want to satisfy their requirements. Why would they ask for Anchor and then give us NCE status before it was completed?