Thank you bear, great post (what's new?!) ......

Yes, "what if" FLD shows that Crestor/Rosu combined with Apabetalone KILLED it with clinical significance? A big "if" but not completely surprising potentially, based on previous data.

We all knew (or theorized) going in that Lipitor inclusion was sub-optimal to the study endpoints. The FDA had to know this also, yet required it, hopefully for the clinical/scientific data knowledge, since a P3 study was occurring, and not as a "deal breaker" should the sub-study data be impressive ... and outweigh the general study & population data.

I STILL see a "short term" path for Rosu/Apa ... "IF" the sub-study data is impressive enough for a well articulated and cogent argument for NDA processing, based on DATA.

This position that we are in now is EXACTLY why we play by the academic rules, and save FLD for the congresses. We may NEED popular support and DEMAND from the medical/academic communities to help our argument. "IF" the FLD is appropriate, we lobby the FDA for an NDa, or at the LEAST a FAST-TRACK P4 for Apabetalone/Rosu ...... and curry all the favor possible with the medical/academic community for published studies, podium time, and support/pressure upon the FDA to hear the case for moving forward ..... ASAP/NOW

A good enough case may be difficult to turn down, considering the potential benefits if the FLD supports it, given the FDA's forced inclusion of Lipitor, despite a failed overall BoM endpoint (statistical significance.

This is why I am banging the Crestor/Rosu drum, and we need to get the medical/academic community banging the drum as well ...... for clinical and patient benefits ...... and an OVER-burdened healthcare costs structure across potentially 3+ major disease states. 

ALL dependent on FLD of course, just some theories, and I am thinking the market is showing early signs of "getting" it also, despite the pie in the face at 7:30 Monday morning.

This is potentially a winnable battle "IF" data provides the fuel and ammo ..... JMHO

1) NDA now ... or, 2) Fast-tracking a P4 (potentially across several indications)

Bang the Crestor/Rosu drum people.

JMHO's based on less than a thimble of info at this point, but strong theories ......