Great post Tada! I just have one clarification to make feeding off of one of your statements: "Make no mistake, if we don't hit the top line numbers we need the share price will make many of us cry."

Top-line data is typically just a statement attesting to whether or not the primary endpoint/outcome measure was met, which for BETonMACE is "Time to first occurrence of adjudication-confirmed narrowly defined MACE." Examples of typical top-line news releases for recent cardiovascular outcome trials (CVOT) can be found here. The BETonMACE top-line data release will most likely just be a postive or negative statement at to whether they statistically achieved a difference between placebo vs. apabetalone groups for time to first occurrence of adjudication-confirmed narrowly defined MACE. The top-line data release should not be expected to reveal the absolute risk reduction or relative risk reduction. The top-line data may or may not get into whether the renal or cognition secondary outcomes met statistical significance. In my opinion, the top-line will only attest to the CVOT results. But a positive top-line data announcement is still a big deal!

Why do I bring this important clarification up? In my opinion, there are 3 major inflection points between now and full data release that each have huge potential.

1) The sample size re-estimation analysis (SSRA) once 75% of planned 3-point MACE events (188) have been adjudicated; expected anytime. Could confirm that the current planned # patients, # target MACE events, & trial timeline will remain unchanged. Or could lead to trial changes resulting in more patients, more target MACE and extended trial timeline. The SSRA will also time stamp the 188 event mark (75% of planned events). In my opinion, if SSRA occurs and no changes are recommended, this is a huge deal because it solidifies that the course remains unchanged for BETonMACE.

2) Top-line data release once the 250 planned 3-point MACE events have been adjudicated. As described above, this will likely just be a statement attesting to whether or not the primary endpoint/outcome measure was met, which for BETonMACE is "Time to first occurrence of adjudication-confirmed narrowly defined MACE." The top-line data release should not be expected to reveal the absolute risk reduction or relative risk reduction. The top-line data may or may not get into whether the renal or cognition secondary outcomes/sub-studies met statistical significance. In my opinion, the top-line will only attest to the CVOT results. But a positive top-line data announcement is still a big deal!

3) Full trial results presented at a major meeting and likley simulataneously published in a major journal. This is where all the nitty gritty details of all the primary and secondary outcome measures for the BETonMACE CVOT will be revealed (summarized here). Detailed data on the BETonMACE safety/adverse events is expected to be revealed with the full trial data too.

Each one of the above 3 events has huge inflection point potential to move this stock. Which direction it goes depends on the results announced for each of these 3 events. Also keep in mind that beyond just the primary outcome are pre-specified subgroup analyses for the primary endpoint in BETonMACE that include:

– Rosuvastatin vs. Atorvastatin

– < 30 days vs. > 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

I'm not 100% sure, but I think that the results of these pre-specified analyses are more likely announced at full CVOT data presentation, and not top-line data reveal. It is also possible that the results of the renal and cognition secondary outcomes/sub-studies be released along with the full CVOT data, but also possible that these results be presented at later conferences and published in other journals. 

Looking forward to this week!

BearDownAZ