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hoc for a drug development program that was not designed to prospectively measure

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cardiovascular risk associated with Saxagliptin. Please discuss whether these endpoints

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and the post-hoc analyses permit a reliable assessment of cardiovascular safety. Please

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offer suggestions for improvements to the endpoints and analyses that may be applied to

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other diabetic programs that have already completed or had ongoing phase 3 programs at

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the time the Final Guidance was issued. Question No. 2 is now open for discussion.

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Sure, Marvin.

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required to conduct pre-planned adjudication of cardiovascular events and to collect

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all data necessary for such adjudication. However, the Saxagliptin development program

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was already complete by the time the guidance was issued. For Saxagliptin, neither pre-

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planned nor post-hoc adjudication occurred and full data were not available to permit

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meaningful assessment of many cardiovascular events.

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guess I wanted to use this opportunity to really thank the FDA because they really

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worked very, very hard on this and approached it, I think, in a sort of a difficult situation

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as systematically as I think you can, and were careful. They did a great job of describing

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their process that they used to get there. I guess, you know, to me again I think that’s the

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best you can do in this kind post-hoc situation. You know, I think they described it well.

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I am sort of reassured that if I remember everything right the, you know, SMQ MACE

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data seem pretty similar to the companies, what you referred to as primary MACE. I

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think the fact that they came out sort of similar is reassuring to me.

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The “SMQ MACE” and “Custom MACE” endpoints were defined post-

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DR. KONSTAM: I mean I don’t - I don’t really have too much to say. I

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DR. BURMAN: Correct me if I am wrong, I think it was the primary - the

company’s primary MACE.

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