everybody around the table completely agrees with that. I do, and I am sure other do as
well. So remember but in this situation as we haven’t really dug into yet, you know, we
have point estimates that are actually extremely favorable, and upper boundaries for the
risk that are, you know, also very far away from the bars, at least one of the bars, that
have been set. So, you know, we do have events. The question is, do we have enough
events to be confident in them?
think we are talking about two different things, okay? I think everybody will agree that
in these studies we need a certain number of events to get any kind of confidence about
what the drug is doing in cardiovascular events. So, you know, we have declared that
cardiovascular safety is important and the only way we are going to get a signal for that is
to have a population study that has enough events, you know, to have confidence in the
events to be confident that the signal is at least in a favorable direction the question
becomes a different question. The question becomes a biologic question. You know, are
you really going to see a different effect of the drug in a different population? I
understand but I just want to sort of separate that’s really a different question than just
making sure you have enough events to see a signal. That’s I guess my point.
So I think that really is what you said a moment ago, and I think
That’s one question for us to deal with. If we feel like we have enough
Scribes, LLC Toll Free 1-800-675-8846 www.scribesllc.com
important, but it doesn’t represent the population of people with diabetes that were
going to be treated, whether in this country or in other countries.
DR. BURMAN: I would go to Konstam first.
DR. KONSTAM: Let me just respond to Kathleen because, respectfully, I