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help us because I mean, I guess, fair enough, I mean, I agree with everything you said,

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but I guess it sort of comes down to why are we even looking at this analysis and I guess

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we are looking at this analysis because there are so few narrower MACE events. So we

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are looking at this analysis I think, and maybe other people can comment, to get greater

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confidence in what the actual upper boundary might be and I guess when I look at that

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drift accepting the non-specificity, it doesn’t help, right? I guess that’s the way I am

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looking at this.

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DR. KONSTAM: Yeah, definitely, yes.

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DR. BURMAN: I assume they weren't obtained?

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DR. KONSTAM: Well, these were just AE reports. That’s all this is, so

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month ago and wasn’t involved in the previous discussions with the FDA guidance. My

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perspective is that the point estimate for SMQ MACE shifts toward one and, if you look

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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

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troponins help, and I don’t think they were gotten, but if they had been obtained, they

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would have been more specific?

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samples drawn along in response to the elevated CK, but and maybe one troponin I saw,

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but in the vast majority not, and I just asked the BMS folks. They don’t have a blood

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bank because that would be another way of going back and checking, but these were

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elevated total CPKs, the vast majority of which didn’t have other cardiac markers.

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DR. KONSTAM: While you are still up there I mean, may be you could

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DR. BURMAN: If I might, one question on that, would getting

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this is with no pre-specification.

DR. ALEXANDER: So on one or two of the cases, there were CKMB

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