Re: Why didn't management do some phase 2's,....
in response to
by
posted on
Jun 19, 2019 08:59PM
Correct Fouremm. It looks like EXAMINE and ELIXA had discontinuation rates in the 20-25% range, incuding patient deaths, other adverse events, voluntary patient declination to continue drug and other unspecified reasons. Discontinuation rate in BETonMACE may be lower or may be higher. We will see.
Cabel asked "In other similar CVOT trials, what is the percentage of deaths as opposed to stroke or a heart attack,...?"
Of the first occurrence 3-point MACE events in the EXAMINE placebo group, 35% were CVD death, 55% were non-fatal MI, and 10% were non-fatal stroke. In total, 4.9% of placebo patients in the trial had CVD death, including additional patients that experienced CVD death after first experiencing a non-fatal MI or non-fatal stroke. Death from any cause (including CVD death) occurred in 6.5% of placebo patients.
Of the first occurrence 3-point MACE events in the ELIXA placebo group, 24% were CVD death, 63% were non-fatal MI, and 13% were non-fatal stroke. In total, 5.2% of placebo patients in the trial had CVD death, including additional patients that experienced CVD death after first experiencing a non-fatal MI or non-fatal stroke. Death from any cause (including CVD death) occurred in 7.4% of placebo patients.
Iconoclast asked "If we do a scenario analysis, what would it suggest re RRR? Let's say 250, 260 and 270 MACE in the trial period (that should cover all scenarios)."
I'm not even going to go there. Too many unknowns.
BDAZ