Biotech Values

[iwfal]

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.

In the MEND CABG II study PR and Trial Description they do not actually say that they will be using as the definition of MI a peak CK-MB level greater than 100. Not knowing anything about this particular metric I'd still be surprised if the FDA allowed this definition of MI.

The reason is that too many times it turns out that the metric is only correlated to the true measure, but not directly coupled or directly causitive. FWIW with two positive trials for peak CK-MB I'd say (very preliminarily) that it looks like the drug does effect CK-MB in some way - but the evidence for it preventing traditional MIs is substantially weaker with only the one trial. Intriguing? Yes. but ... .