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possible, for point number one, before we move to point number two. So the issue with

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point number one is whether the low cardiovascular event rate in Saxagliptin clinical

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trials permit a reliable assessment of cardiovascular safety. This is a summary, albeit

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imperfect, that the studies only examine patients with low cardiovascular risk for a

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relatively short period of time, which may not be applicable to longer studies and higher

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risk patients.

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a pre-clinical signal for a molecular basis for this. Also, as has been said, in diabetes

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this is a continuum disease and a complex disease, so even the ATP 3 guidelines talk

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about patients at high risk and very high risk. So if you have coronary disease and

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diabetes, just like if you have ACS and smoke, that’s a very high risk population as

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supposed to just a diabetic without CAD who is basically a CAD equivalent. So I think

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its complex, its complex.

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risk done in post-hoc adjudication. There is question whether this low risk will apply to

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larger studies in patients who have a higher risk. It seems that many on the committee,

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maybe the majority, think that it may apply, or put in another way as Mike had said, the

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risk from a statistical standpoint of missing a significant cardiovascular event is low.

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Anyone have any, Mark, disagreement with that or modifications? All right, thank you.

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DR. BURMAN: Thank you. Let me try to summarize this discussion, if

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Nonetheless, it appears that there is an acceptable cardiovascular safety

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Question No. 2

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Under the recent guidance regarding evaluation of cardiovascular risk for

diabetes therapies ongoing and future diabetes drug development programs will be

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Then let’s move on to Question No. 2 and we will go for about a half an

hour on this. This is a long question. Oh, you have it on a slide, thank you.

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