I'm missing something on this control group thread. Would all of this knowledge not have been taken into account by the scientists that designed the trial? These scientists, I thought, were/are the top experts in the industry globally. Apabetalone is supposed to outperform the SOC for the conrol group irrespective of how that group has changed over the years. Otherwise, it is not adding to the improvements in SOC so why bother with it. If apabetalone does not add to the existing SOC then why add it's cost into the mix unless there is a significant group of patients or medical conditions that apabetalone helps incrementally.

This trial was designed by the top experts in the world and negotiated with the FDA and revised accordingly. I was concerned about the inclusion of atorvastatin but figured the bio-statiscians in concert with RVX, the clinical steering committee and the FDA powered the statistical design accordingly and then exceeded the power in the final experiment.

I was very concerned about 3 point MACE because we has no data on apabetalone and 3 pt MACE and yet the best experts in the world and RVX people accepted it. We all new the rules up front.

I thought San Fran raised an excellent question about "time to first event" as a valid criteria, but again, it was accepted by the brightest experts in the world and it has been achieved by other drugs. So why did apabetalone fail? I'm sure there must be science to back up the "time to 1st event" criteria and it probably is correlated with other important measures of health like total # of MACE events or intensity of MACE events as a valid scientific measure.

Over the years it is my understanding that we have learned (proven???) that apabetalone impacts many systems in a positive manner - From BDAZ Oct 3 8:23 a.m.  - "But recall there's also benefit in vascular inflammation, vascular calcification, coagulation, complement, acute phase response, and glucose metabolism. Just keep in mind there is no evidence that apabetalone depends on rosuvastatin for these other mechanisms....only evidence for the plaque reduction." My hope -Hopefully all of this will be at least replicated and enhanced in the BoM trial but all of these positive impacts did not result in an increase to "time to first event".

From Don at the Sept 30th presentation - "Quite contraire [sic]. Apabetalone has now confirmed a safety profile worthy of a chronic use drug." So what role will apabetalone play in health? Is it a drug that positively impacts many important systems and perhaps is good for general health over extended periods? This could be possibly a valid business model? I don't have an analogy.

So if all of these positive impacts happen and 3 point MACE is not reduced then what end target does apabetalone achieve and is it a significant enough end point for apabetalone to be approved as a viable FDA approved drug? I'm sure RVX will find out.

I believe apabetalone has also reduced 5 pt MACE in a statistically significant manner (>95% confidence) based on short (6 month) small sample, post hoc analysis of combined trials that hopefully will be replicated and enhanced by the BoM tial length.

We also know that the sample design for BoM was far more targetted than previous trials with patients having CVD, DM, low HDL, etc all of which, I presumed, would have increased the probability of success.

Well, those are my ramblings. Flame me if you like...have at me if you see fit.

I truly appreciate and marvel at the thinking, efforts and posting on this forum. I'm exposed to ideas perspectives and subtleties that I never would have considered on all fronts from science to money to business strategy. Thanks to all.

I'm clinging hopefully to Nov 16th and the discovery of highly signifcant 3 pt MACE findings in a predefined subgroup such as rosuvastatin patients (in particular) and then a clear path forward to an NDA. At that point $ will happen and deals may occur and I believe ZCC could achieve liquidity. If not, then the journey of scientific discovery will continue into the future and I will hold my shares until serendipidy happens.

I'm also clinging to the thought that the p achieved was just slightly less than p=0.05 and that if p~0.06 and there are other positive indications that the FDA will move this drug forward. But remember, Mr Moon was there for a reason.

Thanks to all you incredible thinkers and posters and GLTA.

Toinv