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everybody around the table completely agrees with that. I do, and I am sure other do as

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well. So remember but in this situation as we haven’t really dug into yet, you know, we

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have point estimates that are actually extremely favorable, and upper boundaries for the

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risk that are, you know, also very far away from the bars, at least one of the bars, that

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have been set. So, you know, we do have events. The question is, do we have enough

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events to be confident in them?

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think we are talking about two different things, okay? I think everybody will agree that

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in these studies we need a certain number of events to get any kind of confidence about

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what the drug is doing in cardiovascular events. So, you know, we have declared that

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cardiovascular safety is important and the only way we are going to get a signal for that is

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to have a population study that has enough events, you know, to have confidence in the

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signal.

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events to be confident that the signal is at least in a favorable direction the question

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becomes a different question. The question becomes a biologic question. You know, are

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you really going to see a different effect of the drug in a different population? I

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understand but I just want to sort of separate that’s really a different question than just

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making sure you have enough events to see a signal. That’s I guess my point.

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So I think that really is what you said a moment ago, and I think

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That’s one question for us to deal with. If we feel like we have enough

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important, but it doesn’t represent the population of people with diabetes that were

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going to be treated, whether in this country or in other countries.

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DR. BURMAN: I would go to Konstam first.

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DR. KONSTAM: Let me just respond to Kathleen because, respectfully, I

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