You really need to do some more research before you respond.
"The Phase II trial FAILED."
The Phase II did not fail.
"The Phase II trial showed no change in MORTALITY."
A drug is not going to improve on some mechanical problems.
"The current trial will likely also show no benefit in MORTALITY."
The current trial is not designed to show a mortality benefit.
"The subset in which they claimed statistical significance from my guess is likely n<50 from 900 patients."
Any patient undergoing a CABG will have mycardial damage as shown by increased CK-MB levels. The subset which was not statistically significant was the population with CK-MB < 50. The 250 mg dose of MC-1 had a 14.0% reduction in the primary endpoint composite of death, non-fatal myocardial infarction (peak CK-MB ³ 50ng/ml), and non-fatal stroke versus placebo.
Both groups had less events which is why there is no statistical difference. This group is not being used for the FDA approved Phase III.
The 250 mg dose of MC-1 had a 37.2% reduction in the composite of death, non-fatal myocardial infarction (peak CK-MB ³ 100ng/ml), and non-fatal stroke versus placebo (p=0.028).
The reduction in the composite endpoint was driven by a substantial decrease in the incidence of non-fatal myocardial infarction, most notably a 46.9% reduction in non-fatal myocardial infarction (peak CK-MB ³ 100ng/ml) with the 250 mg of MC-1 versus placebo (p=0.008).
So in the group with a higher CK-MB levels it would seem that MC-1 provided a significant cardioprotective benefit. This is the study group used for the Phase III trial.
The trial will assess the cardioprotective effects of MC-1 compared to placebo in patients undergoing high-risk CABG surgery. Reduced incidence of death is not required.
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