X hits on this document

449 views

0 shares

0 downloads

0 comments

104 / 170

10

assure you that I have used say the glitizones and I have never seen anybody have a heart

11

attack or an adverse cardiac event, which of course is exactly what we are addressing

12

here today. So what are the options for a drug, which obviously does something for

13

blood sugar, and in which you cannot define an adverse cardiac event, and yet you may

14

not have enough data to define it? What are the options in terms of the FDAs dealing

15

with this drug? I am not sure I quite hear that.

4

understanding that glycemia control is important, these therapies have a benefit with

5

respect to controlling diabetes, now the next question is, if that has been established for

6

us, and I know that is not on the table to discuss here, is that whether or not the quality of

7

the data that they have here will address that cardiovascular risk goalpost?

17

give my recollection of the advice we heard about evaluating cardiovascular risk. I am

18

going to qualify that by saying when it's my recollection, I remember quite clearly

19

everything I did in high school. I remember everything I have done in the last fifteen

20

minutes but everything in between is sort of a blur to me. So there may be others that

21

were at that meeting that have a little different impression but I will give you my

22

impression. So what the committee was trying to do is to say, we need to have some sort

23

of balance where we at least know we have some comfort that there won't be a

24

cataclysmic MI result from a drug. Recognizing that to get definitive data would take

103

16

DR. ROSEBRAUGH: So, let me just kind of take us back and at least

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

1

are other programs who had already initiated phase 2, phase 2I are very much well

2

under way.

8

DR. BURMAN: Thank you. Dr. Levitsky.

9

DR. LEVITSKY: So as a pediatric endocrinologist, once again I can

3

We recognize that that is a difficult task before you, but if there is an

Document info
Document views449
Page views449
Page last viewedMon Dec 05 14:15:32 UTC 2016
Pages170
Paragraphs7975
Words54271

Comments