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Re: iwfal post# 43673

Tuesday, 03/27/2007 1:57:32 PM

Tuesday, March 27, 2007 1:57:32 PM

Post# of 257275
I was wrong on hard events being stronger than 20% (with offsetting effects for revasc) but right on glycemic control.

Actually, it turns out I was right on offsetting effects for revasc. The p value of the primary endpoint was almost exactly 1.0 per Feurstein(sp?). I was just wrong on the magnitude of the hard endpoint efficacy. So they will definitely(!) have to run another big heart trial - my guess is they would want a >10,000 patient trial for 3 years but otherwise a similar protocol to ARISE. If I were they I would run it largely ex-US where there is less extraneous revasc for stable angina and I'd want to do some of the imaging that Nissen refered to to prove MOA inre rupture prone plaques.

BTW - I am disappointed in Feurstein. He is completely ignoring the diabetic data. His agenda seems to be to prove that he was right, vs an analysis of what is.

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