Re: 3 point MACE vs 5 point MACE
in response to
by
posted on
Nov 02, 2018 05:50PM
JermaineJackson,
Most top-line data announcements for successful/positive CVOT trials, especially those for first-in-class CVOT trials, only report that they met the primary endpoint without providing a %RRR. Recent examples of this are CANTOS for IL-1B antibody, EMPA-REG-OUTCOME for Empagliflozin SGLT2 inhibitor, DECLARE-TIMI for Dapagliflozin SGLT2 inhibitor, FOURIER for Evolocumab PCSK9 antibody, LEADER for Liraglutide GLP1-R agonist, SUSTAIN-6 for Semaglutide GLP1-R agonist, REVEAL for Anacetrpib CETP inhibitor. Some exceptions to this are CANVAS trial for canagliflozin SGLT2 inhibitor and ODYSSEY for Alirocumab PCSK9 antibody that both reported full data at first reveal, but these two drugs were no longer first in class to report CVOT. Really, the only recent first in class drug to buck this trend is Amarin's Vascepa REDUCE-IT trial that announced it's 25% RRR in 5-point MACE at top-line.
As for statistical significance.....if they announce that they met the primary endpoint, you can assume it met the significance threshhold for that particular trial. Of course, it is better to have a smaller p-value; however, simply meeting the threshhold is the most important thing.
As for my dream top-line release for BETon MACE......too hard to say because there are too many potential outcomes to report. In addition to the primary outcome on the entire trial population, there are a lot of secondary outcomes, sub-group analyses for the primary 3-point MACE outcome, as well as the cognition sub-study and the CKD sub study.
If the stock price hasn't started to significantly move prior to the first top-line data release, then I think it would be best for the simple press release that announces that the primary outcome was met without providing the %RRR. In this way, Resverlogix is in the spotlight and starts getting attention and all kinds of fun wild speculation and stories on the company, the drug, and the potential come out. I call this the teaser scenario....LOL.
BDAZ