help us because I mean, I guess, fair enough, I mean, I agree with everything you said,
but I guess it sort of comes down to why are we even looking at this analysis and I guess
we are looking at this analysis because there are so few narrower MACE events. So we
are looking at this analysis I think, and maybe other people can comment, to get greater
confidence in what the actual upper boundary might be and I guess when I look at that
drift accepting the non-specificity, it doesn’t help, right? I guess that’s the way I am
looking at this.
DR. KONSTAM: Yeah, definitely, yes.
DR. BURMAN: I assume they weren't obtained?
DR. KONSTAM: Well, these were just AE reports. That’s all this is, so
month ago and wasn’t involved in the previous discussions with the FDA guidance. My
perspective is that the point estimate for SMQ MACE shifts toward one and, if you look
at only the CPK elevations, it’s right on one, and if you add a lot of non-specificity, that’s
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DR. ALEXANDER: I mean, the way, again I got involved in this about a
troponins help, and I don’t think they were gotten, but if they had been obtained, they
would have been more specific?
samples drawn along in response to the elevated CK, but and maybe one troponin I saw,
but in the vast majority not, and I just asked the BMS folks. They don’t have a blood
bank because that would be another way of going back and checking, but these were
elevated total CPKs, the vast majority of which didn’t have other cardiac markers.
DR. KONSTAM: While you are still up there I mean, may be you could
DR. BURMAN: If I might, one question on that, would getting
this is with no pre-specification.
DR. ALEXANDER: So on one or two of the cases, there were CKMB