Biotech Values

[iwfal]

Just FYI there is a lot of slop in the words "part of the definition of MI". For example, what if the definition in original trial was exclusively CK-MB>100 but in the pivotal trial it is CK-MB>100 OR changed ST. That could substantially dilute the CK-MB effect if ST and CK-MB are not highly(!) correlated. (Note that I agree that "physician diagnosed MI" benefit counterbalances this to some degree.) The interesting question is exactly what the difference is between the ph ii definition and the ph iii definition. Lots of trials fail on such 'trivial' changes.

For instance the Gusto IIb trial used as the criteria 2 of 3 of the following: CKMB, 2 new Q waves or new regional wall motion abnormalities.