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have that provides some perspective on this would be the Kaplan-Meier curve; if we

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could project slide 57 from the core deck. So, again, we look carefully at the time course

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of when these events occurred and didn’t, our view of the data is that we did not see

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evidence for increased harm for Saxagliptin either earlier or late. We looked at the same

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sort of data for all cause mortality and saw a very similar pattern.

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and retinopathy, where there was an increase originally and then in the end there was a

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major benefit. I'm not really sure of an analogous situation in terms of cardiovascular

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disease and diabetes. You know, it may be that a study like ACORD if it’s followed out

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long enough will show some type of a benefit because the total event rates were lower in

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the intensive group. I think the thing that frequently is referred to is the DCCT results.

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of your question, if we can go back to that it, was whether those patients that have rescue

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and if my memory serves me right it’s about 10-12% of people who were rescued are the

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ones that had a higher rate of cardiovascular events. Can anyone address that issue either

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from the FDA or the Sponsor? Please.

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DR. BURMAN: Thank you. We will take a break at 2:30. the first part

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early increase in events but that it goes away over time. Macrovascular events, yeah,

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not just microvascular events. It may just be it’s because that statement was lumping

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together so many studies.

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DR. BURMAN: Thank you. Dr. Wyne maybe you could follow up as

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well. Did the Sponsor have a comment on that?

DR. WOLF: Given the limitations of our data set I think the thing that we

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DR. SAVAGE: The thing that’s commented on frequently was the DCCT

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DR. BURMAN: Does the FDA have any further comments on that? Dr.

Savage do you have a comment on that?

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