CCD,

"Consistency is crucial in these trials. Would the FDA would think the same?"

Yep, consistent results that are in line with the hypothesized mechanism of drug action can be almost as valuable as statistical significance in a single endpoint.  One of great strengths of the BoM dataset is that for patients in which apabetalone worked, it worked well and it worked consistently over different MACE components.  However, the lack of result in the high HDL group is a complete reversal of expectations that needs an explanation.  The explanation may be closer at hand that I can see (I have no expertise in cholesterol and related biochemical pathways).  And it may simply be a question of dose - do these patients need more apabetalone or sooner?

One thing to keep in mind (for those interested in the drug as well as the stock price) is that in the long run, apabetalone's main use may be as a preventative drug.  Folks won't wait until they are in a diabetic, high LDL, post MACE situation before they are put on it.  It's MOA is unlike drugs we now use to fight chronic inflammation in that it does not yet seem to have any nasty side-effects.  The current immunosuppressive treatments don't fix the underlying problem and have highly detrimental effects on immune function (fighting cancer and infections) in the longterm.  Apabetalone may not solve the problem of chronic inflammation (basically why does a temporary defence mechanism such as inflammation get turned into a constant state in the body), but it appears to be safe for longterm use in controlling inflammation and the associated damage it causes

Back to the high LDL problem, you can bet that the RVX team and advisors are all over it.  Stay tuned...

Jupe