X hits on this document

434 views

0 shares

0 downloads

0 comments

60 / 170

13

the next 20 minutes, until approximately 10:30 a.m., the Committee will have an

14

opportunity to ask questions of the Sponsor and we thought the best way to do this is just

15

open it up to the Committee at the moment and if you have a specific person on the

16

Sponsor you want to answer that, please direct it, if not just direct it generally. Yes,

17

Mike?

4

if it is all right we are going to have our break now for 15 minutes and then come back

5

and have questions for the Sponsor and then move on to the FDA discussion. We will try

6

to resolve the technical issues. On the 15-minute break please remember there should be

7

no discussion of the meeting topic during the break amongst yourselves or with any other

8

members, we will resume at 10:05.

21

consideration, as Dr. Daniels described, the primary objective of that study is to

22

demonstrate the clinical benefit of Saxagliptin going beyond simple glycemic control. So

23

our intent is to work with the FDA and perhaps other health authorities to design that

24

study.

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

1

make in the care of patients with type 2 diabetes. We look forward to your discussions

2

and thank you.

10

CLARIFYING QUESTIONS FROM THE

11

COMMITTEE TO SPONSOR

18

DR. PROSCHAN: This is for Dr. Daniels, who said that there is planned

19

a clinical trial post marketing. I am wondering what will be the comparator in that trial?

3

59

DR. BURMAN: Thank you very much. Because of technical difficulties

9

12

(Morning Break)

DR. BURMAN: All right, why don't we get started? It's 10:10 a.m. For

20

DR. WOLF: The details of the design of that study are still under

Document info
Document views434
Page views434
Page last viewedSun Dec 04 10:18:58 UTC 2016
Pages170
Paragraphs7975
Words54271

Comments