Awesome webcast. DM was very positive and as others have noticed he gave a number of teasers and almost let the cat out of the bag several times.

Between the AHA late breaker session on November 16th, the AHA poster presentation on November 18th, and the "lifting of the kimono" pre-market webcast by Resverlogix on the morning of November 18th, everything except the cognitive function data will be revealed!!!! Cognitive data comes in December at CTAD. He did not explicitly say in the webcast that CKD sub-study results would be presented between Nov 16-18, but it sure sounds like it (RVXoldtimer posted that this was confirmed in the Q&A). The statement of (paraphrasing) "only data to remain embargoed is cognitive impairment data" strongly suggests almost all the beans (minus cognition) will be spilled by Nov 18th, including safety data. Details of the Nov 18th webcast coming soon via news release.

Median dosing of BETonMACE was 114 weeks (range of 24 to 152 weeks). 220 study sites.

He made a few comments indicating the the primary endpoint was barely missed. Paraphrasing: "Powering of the trial was a little light." "Marginal miss." "You'll find out how close we got soon enough." Sounds extremely positive. Surprisingly, he did not talk about the pre-specified sub-group comparisons of the primary endpoint. So if the total population was a near miss, then this bodes extremely well that some of the sub-groups (i.e. rosuvastatin or eGFR<60) had very strong numbers. However, I see in RVXoldtimer's recent post that: "From Q&A, he said that the Atorvastatin/Rosuvastatin breakdown would be given on Nov. 18 as well as CKD results." So there you go.

Pre-specified subgroup analyses for the primary endpoint include:

– Rosuvastatin/Atorvastatin

– < 30 days/> 30 days post-acute coronary syndrome

– LDL/HDL/TG’s above and below median

– HbA1c above and below median

– eGFR >60 mL/min and < 60 mL/min

There will be a face to face meeting with FDA on November 13th to talk about possible ways forward. See slide 16. Still a possibility that they could proceed with current registration of apabetalone based upon BETonMACE data alone. Another possibility is the idea of a BETonMACE continuation trial, or "bolt-on" trial sounded exciting. I didn't know that was a possibiilty. Basically run another X number of patients through the BETonMACE protocol for another 18 months or so to improve powering. Slide 17 went into some examples of non-traditional drug registrations based upon past trials that also didn't hit their primary endpoint. Sounds very promising!

At least 1 new patent planning to be filed soon based upon BETonMACE data! Sorry Cancundude, I don't have any clue what this is.

Don said that some of the clinical steering committee members asked if they could stretch the embargo until the end of March to present at a major meeting there. He was probably referring to the American College of Caridology 2020 meeting (being held jointly with World Congress of Cardiology). Sounds like Don laughed this idea off. March would be a LONG LONG time to wait!

Lots of data going to be shared Nov 16-18. So concerns that not everything can be fit into the 8 minutes of hte AHA late breaker should now be alleviated. In addition to the AHA late breaker on Nov 16th, and AHA poster session on Nov 18th, Resverlogix plans to go into detailed results in the Nov 18th pre-market webcast. The presentation of multiple endpoints via the forest plot (slide 10) has the potential to make a big splash and really sum up a lot of effects that could prove apabetalone is efficacious. Not just first occurence to primary 3-point MACE endpoint and first occurence of 5-point MACE secondary endpoint, but also:

"First and recurrent primary endpoint events

Cardiovascular death or non-fatal MI

Coronary heart disease death or non-fatal MI

Cardiovascular death

Stroke

All cause mortality

First hospitalization for congestive heart failure

First and recurrent hospitalization for congestive heart failure

First occurence of primary endpoint excluding undetermined death"

Add on to this other secondary and exploratory endpoints not listed above from the BETonMACE design and rational paper or BETonMACE ClinicalTrials.gov listing:

Change in estimated glomerular filtration rate (eGFR) among the subset with baseline eGFR less than 60 ml/min/1.73m2. Changes within and between treatment groups over time in lipids (HDL-C, LDL-C, triglyceride), apo-AI, apoB fasting plasma glucose, fasting plasma insulin, hemoglobin A1c, alkaline phosphatase, hsCRP, inflammatory cytokines and fibrinogen. Plus a broad exploratory endpoint looking at RNA profile (transcriptional messenger RNA changes) in whole blood and/or leukocytes, as well as health-related quality of life assessed with the EQ-5D-5L.

So all of the above should be revealed by November 18th! The only thing not revealed should be cognitive function assessed with the MoCA that we will need to wait until December for.

Very exciting.

BearDownAZ