talking and if it’s okay with the rest of the FDA, we have a few minutes before noon and
would it be okay to open up questions not only for the FDA but for the Sponsor as well,
is that okay? Does anybody on the committee have any additional questions on any of
the presentations this morning? John?
commitment but a desire to be in active dialogue with regulators and I think also
academic groups that prudentially want also to have some input into the design of the
study as well. So, I just want to make sure I can covey that as a sort of the senior medical
authority for BMS and I think in consultation also with our AstraZeneca colleagues that
the commitment is there, it’s real. It seems maybe a little bit unformed, but it’s unformed
I think because we really want to have the right discussions both with the FDA, other
regulatory authorities and academic groups as to how best to continue to develop the
cardiovascular profile and other meaningful outcomes for Saxagliptin. Thank you.
any of the analyses that we had asked for in terms of showing distribution in terms of the
stages of Coronary Kidney Disease, in terms of distribution along those lines and the
other extra things that I had requested before. I know we can wait till perhaps after lunch
if you need the extra time, but I do want to see those.
DR. BURMAN: Thank you. I think if it’s all right, Paul and I were
DR. TEERLINK: I was just wondering if they have had a chance to do
think the issue is that the study design is actually relatively unformed because we
want to make sure we can have the right discussions with both the FDA and other
regulatory agencies who are interested in this question.
DR. WOLF: Could we have the slide on use of Statins by treatment
group? Please project slide 3-58. This slide describes the use of Statins based upon
So in essence, the lack of certainty of our design reflects not a lack of
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