X hits on this document

430 views

0 shares

0 downloads

0 comments

96 / 170

13

even though they are - when referred to placebo control, it's actually add-on. So they

14

were standard background therapy. In our guidance, we do not specify what that

15

comparator should be and we are actually very specific in terms of assessment risk as to

16

all comparators as you will hear in the subsequent discussion. It's very difficult to define

17

or state up front what that comparative must be. It has the complexity and I think a lot of

18

the diabetologists and endocrinologists around the room here could speak to that as well

19

as the complexity of the disease will make it very difficult to say that this must be the

20

comparator for which, and overtime to do a long-term study to assess cardiovascular risk,

21

it's also going to be multiple therapies that will eventually be added on to both groups.

5

relative to. I mean apparently it seems that sometimes when you compare to an active

6

comparator, it actually comes out better than when you compare it to the placebo and,

7

given that many of the drugs that have already been approved were approved on a basis

8

of HbA1c, it's possible that those drugs also have cardiovascular harms. So showing that

9

it's better than one of the approved drugs might not be saying that much. So does the

10

FDA have a position on what that comparison should be, what that active comparator

11

should be for example?

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

12

DR. PARKS: I think it is important to point out that in this program here

1

mean I guess the deal is you get more events, you take the non- specificity, you try to

2

reach some reassurance and you see what you get.

22

23

95

3

DR. BURMAN: Thank you. Dr. Proschan.

4

DR. PROSCHAN: I guess one of the difficult issues is, what the 1.8 is

comment?

DR. BURMAN: Thank you. Dr. Teerlink, did you have another

Document info
Document views430
Page views430
Page last viewedSun Dec 04 03:59:36 UTC 2016
Pages170
Paragraphs7975
Words54271

Comments