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DR. PARKS: Dr. Wyne, are you referring to an advisor committee in July

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2007? I think that’s the only thing I can think of where there was some discussion about

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last couple of meetings of this committee, with respect to diabetes studies and events, is

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weren’t we told that there tends to be an increase in events in the short-term, perhaps in

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the first six months, but then if you follow the people out for two to three years you get a

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decrease in the events in the treated group. So although it makes sense to me that there

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should be more events the longer you follow people actually what I think we are seeing

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here is even less events than we would have expected which maybe is a positive, that we

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are not seeing that increase in events in the first six months that we have seen with so

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many previous drugs.

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risk in short-term trials versus long-term trials. If that is indeed then the problem is that

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we are talking about not a single study or even a single data set here, they are two very

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different data sets, this is specific to the rosiglitazone advisory committee. The meta-

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analysis, which was comprised primarily of six months or shorter duration studies versus

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long-term studies that were three years, you really can’t compare those two different data

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sets to say that the risk was different over time. Joy, do you want to comment on that?

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Also one thing that was confusing to me is my recollection from the

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DR. BURMAN: Thank you. I would like for clarification of that from

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any members of the FDA or the Sponsor respond to the second part of the question. I

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analysis where we were seeing some early events and then the curves came together?

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DR. WYNE: I actually think it was a meeting prior to that but what I

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remember is a comment of, oh, yeah, this is typical in diabetes studies that we see an

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don’t remember that myself...about there being less events in the longer term?

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DR. MELE: I was just thinking of proactive actually. Didn’t we do some

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