and the Sponsor, I mean everyone has done a great job analyzing the data we have. I
think that one of the challenges I am having is; we actually have examples of multiple
trials where there have been 40 events in a trial. That when the trial has been repeated
with more events not only has a beneficial effect been shown, but it’s been overwhelmed.
So, all right, so I’ll have to wait for that later.
MACE. The custom MACE was similar to the Prime MACE. I think you learn as you
go. I think the discussion about creatinine kinase levels, you know, has emerged and,
you know, I guess I share others concern that is extraordinarily nonspecific. I think going
forward, you know, you might want to reconstruct it without that. You know, I think
you’re going to be left with the problem of, do you have enough events to count and
that’s a problem I guess that you can’t solve by putting in a completely nonspecific
element to it. So I mean I think you guys did a pretty good job.
inclusion of other kinds of events that indicate an ischemic event like, need for
revascularization, you know, unstable angina like events that I guess might not be
captured in the custom MACE one, that I think would be another direction that I would
say might be very fruitful in looking for a meaningful broader event category.
DR. BURMAN: Thank you. Are there other comments? John?
DR. TEERLINK: So I would just want to second that the FDA has done,
DR. BURMAN: Are there any other comments?
DR. KONSTAM: I have one thing.
DR. BURMAN: Of course.
DR. KONSTAM: I think the other that’s come up is the potential for
DR. KONSTAM: I am sorry the custom. I didn’t mean the SMQ
DR. BURMAN: Thank you. Mike.
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