Or there is a number 3 that involves them just not making a decision until 5 years is up, perhaps they had decided to grant NCE with the letter that was circulating and there were lawsuit issues so they just decided they will sit on the decision and de facto grant NCE without ever granting it.
Or there is the number 4 related to the citizens petition on Lovaza needing to be finalized(though that was not even filed until 6 months after Vascepa approval so why the 6 month delay then?)
I see your points but Anchor has zero relation to NCE, there is nothing in NCE guidelines that would make Anchor have anything to do with NCE-the drug is not changing at all and NCE is solely about the drug and whether or not it is a new chemical entity, yes or no on Anchor has zero bearing on that. It's possible someone at the FDA said, I feel better defending a lawsuit IF Anchor is approved as we can argue it is clearly different from Lovaza in makeup proven by the different results but even then the results are already known so approving Anchor changes nothing in regards to what Vascepa does and is. it's very hard to come up with any logic based on facts where Anchor approval had any bearing on NCE.
At least FDA guidelines specifically say there should be an Adcom for any NCE possible drug, it doesn't even clearly state what the Adcom needs to be about so it is all rather vague.
It seems every past speculation as to what they are waiting for has been wrong and despite all we speculate, in the end, its probably something never mentioned by any of us.
