DR. PARKS: No, all the analyses are of first events.
DR. WYNE: So there…
DR. PARKS: There weren’t really multiple events in these studies.
DR. WYNE: Okay.
DR. PARKS: I don’t know if the company wants to confirm them, but
measuring the sensitivity, and I think we agree that they are reasonably sensitive,
there could be a slight chance that they are wrong and over the longer term there will be a
higher rate of adverse events, but that likelihood seems low. Okay. Everyone agree with
that? Also I think we have time to, number one, go back and does anyone have any
further comments on questions one through four that they want to bring up or for their
criterion. I think it would be helpful to sort of reframe that instead of - because it doesn’t
sound good, it doesn’t sound good to say oh we ruled out a harm of a relative risk of 1.8.
That still allows a possibility of a very harmful drug. So, I think it would be good to sort
of rephrase that by, first of all, thinking in terms of one sided confidence interval instead
of two sided, since you are really only concerned about one direction, and then may be
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earlier. All of these events in the custom MACE those were not first events, they were
total events, correct?
DR. WYNE: We just had a quick question we were trying to clarify
DR. BURMAN: Thank you. Mike.
DR. PROSCHAN: I just want to make one more point about the 1.8
that’s what I observed.
DR. WOLF: We agree with that, I believe - I recall there were two
subjects who had more than one event, but it was really a minority of them.