The only plausible reason for the FDA to continue to delay NCE decision is because they are STILL unsure whether to allow/deny NCE.
My thought is that they are waiting for some catalyst in order to make a final determination. Employing this logic, I would look at the possible changes or announcements that the FDA could be waiting for (patents?).
I'm open to other ideas, but I can't think of any other reason the FDA would continue to delay the decision.
I don't know and none of us know and Joe won;t tell us what the detailed discussions got him for feedback.
FDA is constantly changing NCE guidelines so it is possible time from extra trials to now they changed so FDA does not want to grant NCE now. But since they basically promised it to AMRN they are trying to figure out what to do.
OR they plan to grant but attorneys want to review patents and other data to satisfy the ability to defend any lawsuits.
There could be a disagreement among FDA officials themselves.
AMRN believes they have a strong case but FDA may not agree-from 8-K, not sure how to take that.
Another possibility is AMRN is aware the FDA is intending to only grant NME (3 yr exclusivity) but has requested a delay in putting this in the OB because the "exclusivity clock" wouldn't start ticking until the OB is issued.
This could be a compromise position that both parties could agree to: AMRN would wind up with a 3 yrs + however long the FDA delays, in return for a promise not to sue the FDA for requiring them to conduct the REDUCE IT trial, which would likely run longer than the 3 yr exclusivity period.
That has to be a pretty good legal arguement, IMO. Can the FDA require a company to conduct a trial that would still be underway while they are in process of approving a generic competitors' drug?
I personally believe that Amarin wants the patents in the Orange Book at time of issue. I think Amarin and the patent office are the reason for delay. I think they want all of their ducks in a row before the NCE is issued.