Biotech Values

[iwfal]

That is extremely important information. I'll probably sell if true. Where can I read about it?

I was incorrect (slipped a digit somewhere). It does show more death/stroke in the treated group - but not to p<0.2. Apologies. The analysis is:

1) There were about 49 vs 31 stroke, MI and death events (MI being CK-MB>100)

2) There were about 43 vs 23 MI events

3) Therefore there were about 6 death/strokes in placebo group and 8 death/stroke in the treated group.

So I would agree that this is not indicative of anything much. FWIW.


I called Hogan Mallally on your point. He cited 4 other trials in which the FDA had agreed to the definition including the above specs. He confirmed to me that the protocol did include the 100 ng/ml as part of the definition of MI.

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.

FWIW.