...change of fortune we may have on our hands.  I'll restate what many on the board have already mentioned, in the hope that someone may correct me if warranted: the "draft guidance" issued seems tailored to fit BETonMACE.  Thank you to Kipk and Koo for the link:

https://www.raps.org/news-and-articles/news-articles/2019/12/fda-drafts-guidance-on-demonstrating-substantial-e

Though if adopted, all of the flexibility seems possitve for RVX, consider this statement in particular:

In addition to the “gold standard” randomized, double-blinded, controlled superiority trials, which FDA says are “regarded as the most rigorous design,” the guidance also discusses other types of designs, including placebo concurrent control, dose-comparison concurrent control, no treatment concurrent control, active treatment concurrent control and historical control designs. (bold/italic added by me)

One thing DM has made a consistent point of emphasis is that "placebo" in BoM actually means "top standard of care".  I would wager that if, instead, apabetalone was compared against "no treatment concurrent control" for diabetics with heart failure...we would be looking at a starkly different data set. Though it would be unethical to not provide such patients with that standard of care for a trial, does this offer a back door to compare it against the statistics for the entire population of such patients, or does the fact that we provide the standard of care in addition to apabetalone taint our numbers?

As with any bureaucratic process, I'm sure the adoption of these standards could take a very long time. However, I can't imagine that this does not shape and color the way the FDA is currently operating to some degree.  

Wish we had more information about RVX's interactions with FDA, but maybe the deafening silence has an explanation after all. Am I wrong in thinking an anouncement of an updated, successful verdict for BoM could spring at any moment?