Biotech Values

[daved]

re MCU p2 results link:

http://www.findarticles.com/p/articles/mi_m0EIN/is_2005_Dec_5/ai_n15894504

Note that the primary endpoint moves from a stricter definition of MI and a link to stroke to an SPA agreed looser definition and no reference to stroke in P3.

I was pretty sure that the FDA would have insisted on the new post 2004 definition of MI which includes troponin measurement. I made the call to the company to clarify the SPA for P3. My assumption proved untrue. Troponin is not even measured in the trial.

Several recent SPA approved trials are using the peak CK-MB 100ng/ml definition of MI. That is what Medicure is using with FDA agreement. Hogan says the newer definition that includes troponin levels is more appropriate to ACS and that the higher Peak CK-MB numbers are the current gold standard definition for those who have had are have been supposed to have had a previous MI.

Dave