additional cardiovascular data are needed to address any limitations resulting from the
completed clinical development program and to support approvability including
satisfying the 1.8 non-inferiority margin. In the past, when we’ve had questions, there
has been active discussion regarding the questions, and I don’t know if there will be or
needs to be today, but I will open the discussion and ask for any comments regarding the
question or clarification if someone doesn’t understand it. This is a first, not only that,
we may actually end early, no discussion? FDA, no? All right. Are we ready? Okay.
Then as I just read in, the questions on the board, and we just vote, let me just give one
last opportunity for discussion. Everybody is satisfied. Okay.
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
individual who voted will state their name and their vote into the record as well as the
Question No. 1
Based on the proceeding discussion, has the applicant provided
reason why they voted as they did, however, before we vote we do want to have a
discussion of the questions and let me - and we have the first question on the board,
which is as follows, there are two questions to vote on.
appropriate evidence of cardiovascular safety to conclude that Saxagliptin rules out an
unacceptable excess cardiovascular risk relative to comparators, including evidence that
the upper bound of the two-sided 95% confidence interval for the risk ratios/odds ratios is
less than 1.8?
A. If, voting “No,” as we go around the room, we would like what