FDA can change its mind or introduce a new policy that might delay Anchor approval
yes they have done that in the past and very well could do again. that is the biggest risk I see. FDA can change their mind at the last minute forcing Amarin to do additional trials before Anchor approval.
That can happen where the trial results are marginal or unclear. That's not the case here. What are you thinking the FDA might base such a decision on, seeing a dead white cat on the way to the office?
NOT UNDER a SPA agreement the can't.. That's why it is a legal agreement separate from the way normal trials are conducted. Plus the trails were complete over a year ago. If there were any additions or questions they would have stated them b4 accepting the sNDA..
This is why you have to do DD... Nothing will be done last minute to delay Anchor, that is why the trials were done under the FDA SPA agreement.. Plain and simple. What can be done bc Anchor was under a SPA is approve Vascepa for Anchor ahead of Dec 20th.