X hits on this document

408 views

0 shares

0 downloads

0 comments

107 / 170

14

talking and if it’s okay with the rest of the FDA, we have a few minutes before noon and

15

would it be okay to open up questions not only for the FDA but for the Sponsor as well,

16

is that okay? Does anybody on the committee have any additional questions on any of

17

the presentations this morning? John?

5

commitment but a desire to be in active dialogue with regulators and I think also

6

academic groups that prudentially want also to have some input into the design of the

7

study as well. So, I just want to make sure I can covey that as a sort of the senior medical

8

authority for BMS and I think in consultation also with our AstraZeneca colleagues that

9

the commitment is there, it’s real. It seems maybe a little bit unformed, but it’s unformed

10

I think because we really want to have the right discussions both with the FDA, other

11

regulatory authorities and academic groups as to how best to continue to develop the

12

cardiovascular profile and other meaningful outcomes for Saxagliptin. Thank you.

19

any of the analyses that we had asked for in terms of showing distribution in terms of the

20

stages of Coronary Kidney Disease, in terms of distribution along those lines and the

21

other extra things that I had requested before. I know we can wait till perhaps after lunch

22

if you need the extra time, but I do want to see those.

13

DR. BURMAN: Thank you. I think if it’s all right, Paul and I were

106

18

DR. TEERLINK: I was just wondering if they have had a chance to do

1

think the issue is that the study design is actually relatively unformed because we

2

want to make sure we can have the right discussions with both the FDA and other

3

regulatory agencies who are interested in this question.

23

DR. WOLF: Could we have the slide on use of Statins by treatment

24

group? Please project slide 3-58. This slide describes the use of Statins based upon

4

So in essence, the lack of certainty of our design reflects not a lack of

Scribes, LLC Toll Free 1-800-675-8846 www.scribesllc.com

Document info
Document views408
Page views408
Page last viewedFri Dec 02 20:36:11 UTC 2016
Pages170
Paragraphs7975
Words54271

Comments