Re: Is there any hope here??
"Until the surprise last October, the FDA only required Amarin to have Reduce-It trial substantially enrolled. Prior to that the FDA did not ask for the extended CV study to be completed."
I've worked with several federal agencies in various capacities. The FDA would not have asked for the study had they not wanted to see the results. Agencies change their mind/course a lot. Asking for the study was the beginning of their changing of thought on this. I had several PMs with several folks on this board before October regarding concern about this. I was not the only one watching this with that fear in mind.