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additional cardiovascular data are needed to address any limitations resulting from the

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completed clinical development program and to support approvability including

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satisfying the 1.8 non-inferiority margin. In the past, when we’ve had questions, there

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has been active discussion regarding the questions, and I don’t know if there will be or

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needs to be today, but I will open the discussion and ask for any comments regarding the

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question or clarification if someone doesn’t understand it. This is a first, not only that,

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we may actually end early, no discussion? FDA, no? All right. Are we ready? Okay.

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Then as I just read in, the questions on the board, and we just vote, let me just give one

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last opportunity for discussion. Everybody is satisfied. Okay.

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So question number one is on the board and is now eligible for voting.

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the vote from the screen into the record. Next, we will go around the room and each

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individual who voted will state their name and their vote into the record as well as the

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Question No. 1

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Based on the proceeding discussion, has the applicant provided

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reason why they voted as they did, however, before we vote we do want to have a

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discussion of the questions and let me - and we have the first question on the board,

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which is as follows, there are two questions to vote on.

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appropriate evidence of cardiovascular safety to conclude that Saxagliptin rules out an

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unacceptable excess cardiovascular risk relative to comparators, including evidence that

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the upper bound of the two-sided 95% confidence interval for the risk ratios/odds ratios is

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less than 1.8?

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VOTING QUESTIONS

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A. If, voting “No,” as we go around the room, we would like what

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