Thank you Sharon, one thing stands out and that was the note from Citi: "Standard 74 day letter appears very clean and appears even cleaner that that received for the MARINE filing. The FDA's Day 74 letter is where the agency communicates any initial filing review issues and preliminary plans to hold a Advisory Comm meeting"
I think this means the FDA sees little in the way of issues for ANCHOR. This is about 10x the importance of that Summer Street misquote of Dr. Brinton IMHO.
I don't believe safety is an issue at all with the FDA re Anchor. Vascepa is obviously safe.
I think the issue will be whether or not it will have material benefits to the lower TG groups
versus what is already available to them, ie, low dosage statins, etc. This is a precedent
setting decision really if you think about it. Insurance will be affected.
Given all the recent negative publicity on fish oils in general, I think the FDA could be careful here.
They might well want to see prelim Reduce It results before approving. It's not a life or death situation right this now so IMHO approval is not a slam dunk.