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and Liraglutide to assist cardiovascular safety, but it’s important that each application be

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evaluated on its own merits. Today you will hear about Saxagliptin and get to vote on

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Saxagliptin. Tomorrow you will hear about Liraglutide and get to vote on Liraglutide.

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These development programs differed and cross program comparison should not be

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performed.

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conducted are post-hoc analyses based on MedDRA preferred terms. There was no

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prospect of adjudication of cardiovascular events, and there was no prospect of

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adjudication either. Post-hoc adjudication was not conducted because many events had

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insufficient information for adjudication, getting back to this issue that these programs

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were not pre-specified to measure cardiovascular risk, and therefore they were not setup

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to always collect all the necessary information needed to definitively say whether event

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was due to a cardiovascular event of interest or not.

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asked to talk about toward the end of the day, and also the voting questions. I’m

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presenting them now to provide a framework for the panel as they hear presentations over

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the course of the day, so they can see the types of information FDA would like to obtain.

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So, the four discussion points on this slide apply both to Liraglutide and to Saxagliptin,

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which you are hearing about today. We would like the committee to discuss whether the

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low cardiovascular event rates, the endpoints, and the post-hoc analyses permit a reliable

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assessment of cardiovascular safety.

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As I mentioned before, FDA used the uniform approach for Saxagliptin

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I would now like to end with the discussion points that the panel will be

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event to be classified as a myocardial infarction it would need to meet criteria A, B, C,

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and D.

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The analysis you will be hearing about that FDA and the applicant

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