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of diabetes, what I was actually looking for was a sub-group analysis of the patient’s

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event rates looking only at those who had diabetes for ten years or longer, since that is

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actually going to be the bulk of the patients who will, in the real world, be receiving this.

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You know, if we are going to be trying to look at that group, I think it would be useful to

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look what happened to cardiovascular events in the patients who had diabetes of at least

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ten years’ duration. Unfortunately that’s only 10% of the patient population but it is, you

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know, it is what it is. So that’s what I actually had been interested in saying.

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committee have a specific question on those several slides? Thank you for doing that so

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rapidly. I would now like to maybe give you an overview. We will have, as long as it

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takes, usually 20 maybe perhaps 20-30 minutes, of questions for the FDA and the

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Sponsor if there are any. When that is done, we will then move to discuss each question

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of the four questions; we will spend about a half an hour on each question. Depending on

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time, we would like to end that session around 4:00 or sooner, we then want to have an

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hour left aside if needed for the specific voting questions. Any questions on the agenda?

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DR. WOLF: I’m sorry I didn’t fully appreciate the question you were

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asking, but we do have an analysis at least for patients who have at least five years of

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(No response.)

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Then let me open the floor up for any further discussions or questions or

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DR. BURMAN: Thank you very much. Does anyone on the

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DR. BURMAN: Thank you. Anybody else on the committee have any

questions? The Sponsor wanted to make a comment? Please.

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disease. You are not interested? Okay.

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

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comments by the committee to the FDA or the Sponsor. John?

DR. TEERLINK: So just to clarify my earlier question about the duration

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