X hits on this document

534 views

0 shares

0 downloads

0 comments

102 / 170

12

revascularization events in a setting of a hospitalization recurrent ischemia. Perhaps that

13

can tease out, I don’t know what the incidence of revascularization in the database was.

14

The other observation would be we are looking at only first events. Obviously there are

15

other events that occur if the first event was non-fatal such as an MI, then a stroke, then a

16

CV death. So there is other ways of potentially enriching for events by looking at other

17

events or secondary or tertiary events.

6

others have told or have mentioned that very nicely, symptoms, EKG changes and/or MB

7

positivity or troponin positivity. If we are talking about other events and I think the

8

guidance allows for other events besides CV death, MI and stroke, and that is really a

9

recurrent myocardial ischemia or new myocardial ischemia leading to revascularization

10

where perhaps a CPK MB or troponin periprocedural may show myonecrosis.

21

cardiovascular safety at that point in time was our endpoints of acute CV events and that

22

event included revascularization procedures and you recall that we had 41 cases of

23

primary MACE on our data seg. We had approximately 60 cases of acute CV events.

11

So in order to perhaps maybe improve upon the events, we have excluded

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

1

developed the troponin ANSAID. So what I am trying to say is the answer to your

2

question is, we would look at that elevation and not even think myocardial ischemia in

3

routine clinical practice nowadays.

18

DR. BURMAN: Does either the FDA or the Sponsor have a comment

101

4

DR. BURMAN: Any other comments? Dr. Veltri, you had a comment?

5

DR. VELTRI: I was commenting on the diagnose of MI, but I think

19

20

regarding that especially the issue of revascularization?

DR. WOLF: Before we submitted the NDA, our primary assessment of

Document info
Document views534
Page views534
Page last viewedSat Dec 10 08:32:12 UTC 2016
Pages170
Paragraphs7975
Words54271

Comments