Cancun, that's my BURNING question as well obviously, since it was the FDA's insistence to include a drug (Lipitor) in for the overall data. It would seem a downright shame on MANY levels to hold something back that shows real promise ... "IF" that is the case from the FLD. 

Not a researcher, but I would love to hear of any other similar scenarios and precedents where the primary endpoint failed, but an NDA and approval path was granted based on sub-studies? I feel this is a unique situation given the way the study was constructed, and at the FDA's request? ... if the sub-study data is compelling enough, and given the safety profile?

Maybe I am just holding out irrational "hope" that there is a path remaining, or at least a cogent argument for Crestor/apabetalone within the FLD? ... while avoiding the time, expense, and delay to patients that an additional P3 study would require?

If the FLD is suggestive/supportive enough, that is where I would spend whatever money, resources, influence right now to inspire enough confidence to re-create partnerships, funding, etc to not only get Cardio back on a fast track, but clear the path additionally for Renal & Cognitive fast-tracking (pending FLD of course) and their potential P3's with the precendence of apabetalone moving toward approval, and some cash rolling in supportively.

Even if not approvable on that path, I would STILL make a big enough stink about it to show the world that is looks "REAL" ... save for some study technicalities and arguable formalities.

I'm in "bulldog" mode now ... FLD tick tock