I'm going to start by saying, this is just a theory until FLD ... I will also say that I am VERY disappointed about the BoM TLD for "primary" endpoint, I am NOT upset with RVX at this point ... so much more info to come between now and AHA.

IF ... the Crestor combination rocked it to primary endpoint satisfaction, and was weighed down by Lipitor, ... AND this prevents apabetalone from advancing within the approval pathway, that is negligent on the part of the FDA.

Data was previously known about the difference between the two, when combined with Apabetalone. RVX wanted to pursure the Crestor combo, for which RVX owns the combination dosing patent. This combination was RVX's study desire for obvious clinical and business reasons, but it shouldn't get lost that it appears to be (from ASSURE post-hoc) a winner and of GReAT benefit to patients, and shown to be VERY safe pending further P3 analysis. At the FDA's insistence, a KNOWN relative "dud" was forced into the equation for the total population numbers and statistics. Crestor appears to dominate market share as well. 

To be clear, I do NOT have a problem with the inclusion of Lipitor, I think that is a good thing for science and study.

However, if my "theory" is correct, and Crestor shows it met the study efficacy and safety objectives and endpoints on its own, AND is not allowed to proceed on an approval pathway, then I consider this to be negligent on the part of the FDA with regard to patient health, and also patient/insurance/system wide financial considerations.

IF ... the above scenarion pans out (FLD) I would hope RVX goes HARD at the FDA (legally if necessary) for consideration of Crestor/Apabetalone ... as well as any secondary indication for upcoming P3 trials .... esentially, taking Apabetalone off of an approvable path not only slows a promising drug from market for cardio, but also slows the advancement to market in other areas with Renal & Cognitive as well potentially due to finances and sending RVX into a circus level tailspin for survival rather than focusing on good science work ahead ... (like our U.S. congress, maybe someday they will be able to focus on the good work they were sent to Washington to do, rather than a myriad of distractions).

The "rigororous" academic standards are awesome, ... but now gtf (fudge :) out of the way of progress, safety, health, system-wide financial struggles for many.

I'm in a fighting mood and spirt, not feeling "sorry" one bit ... I want a piece of somebody's "behind" if it turns out like a theorize, and nothing id done about it ......

FLD ... tick tock