of diabetes, what I was actually looking for was a sub-group analysis of the patient’s
event rates looking only at those who had diabetes for ten years or longer, since that is
actually going to be the bulk of the patients who will, in the real world, be receiving this.
You know, if we are going to be trying to look at that group, I think it would be useful to
look what happened to cardiovascular events in the patients who had diabetes of at least
ten years’ duration. Unfortunately that’s only 10% of the patient population but it is, you
know, it is what it is. So that’s what I actually had been interested in saying.
committee have a specific question on those several slides? Thank you for doing that so
rapidly. I would now like to maybe give you an overview. We will have, as long as it
takes, usually 20 maybe perhaps 20-30 minutes, of questions for the FDA and the
Sponsor if there are any. When that is done, we will then move to discuss each question
of the four questions; we will spend about a half an hour on each question. Depending on
time, we would like to end that session around 4:00 or sooner, we then want to have an
hour left aside if needed for the specific voting questions. Any questions on the agenda?
DR. WOLF: I’m sorry I didn’t fully appreciate the question you were
asking, but we do have an analysis at least for patients who have at least five years of
Then let me open the floor up for any further discussions or questions or
DR. BURMAN: Thank you very much. Does anyone on the
DR. BURMAN: Thank you. Anybody else on the committee have any
questions? The Sponsor wanted to make a comment? Please.
disease. You are not interested? Okay.
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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