13

DR. KONSTAM: I don’t know if the Agency wants to comment?

14

DR. FLEGAL: Which estimates are you comparing from that table?

15

DR. KONSTAM: Well, I am just trying to figure out looking at the broad

1

to reconcile the data that you presented with what's in the FDA documents and

2

specifically looking at your, I guess it's slide 62, stratified analysis of FDA defined

3

MACE, and looking specifically at the SMQ MACE, not the custom MACE. Then I go

4

back - I go into the FDA document and what I am looking at is on page 37 of the FDA

5

document table 16, I don't know if that's the best place to look or not, but, I am not - and

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maybe these are different analyses and they need to be clarified because your upper

7

boundaries are lower than the FDA's upper boundaries and I don't know if somebody can

8

help me reconcile, am I looking at the wrong things or?

19

their bottom estimate, the incidence ratio which had an upper bound of 1.37 and but the

20

exact method will generally give you a wider confidence interval, so that explains that

21

difference of 0.05.

63

10

methods. I believe that there were some differences in some of the methologic

11

procedures. I know that in some cases the agency calculated odds ratios. Our analyses

12

were primarily based upon risk ratios using the methods that we described.

16

SMQ MACE definition and so I look at the ST plus LT number I get 1.42 for the upper

17

boundary, for the odds ratio. So, are these just - and I don't know what they do.

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DR. WOLF: I would ask the Agency to perhaps to comment on their

18

DR. FLEGAL: Right. So that estimate would be most comparable to

24

ratio for the FDA defined endpoints. If I could please project slide 3-7, so in this slide, in

22

DR. KONSTAM: Okay.

23

DR. WOLF: If I could, we also use an exact method to calculate the risk