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Alias Born 11/13/2006

Re: iwfal post# 41427

Thursday, 02/01/2007 9:27:40 AM

Thursday, February 01, 2007 9:27:40 AM

Post# of 257269
Re mph/mcu mortality from iwfal. That is extremely important information. I'll probably sell if true. Where can I read about it?

BTW, I agreed with your earlier statement that nowhere in writing is it established that the protocol calls for an MI definition including peak CK-MB > 100ng. The post P2 meeting with the FDA reported April 12, 2006 indicated that probability.

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.

Dave

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