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know, something that was a submission before the guidelines were in place. How do we

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look at it? I was overall very sanguine about this particular treatment but I wanted to

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point out that we are talking about lots of diabetics with lots of different needs, with lots

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of risks that they have to assess. I am not sure where I am wondering off to there but I

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just wanted to bring that back up to the panel. Thanks.

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‘one size fits all’ is a little disadvantaging a certain increasing population of diabetics

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who are younger at onset and face many, many years of treatment. They face these

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increased cardiovascular risks because of their diagnosis. If you are developing diabetes

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at 35 instead of 55, you are going to have a good 20 years of treatment ahead of you

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before you really start to focus on the cumulative effect of your diagnosis, your treatment,

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your ability to control your diabetes.

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bringing them up. Diabetes is a complex disease and for purposes of discussion we

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divided into the Type 1 and Type 2 but obviously it’s much more complex than that.

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John, did you have a comment as well?

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DR. BURMAN: Thank you. I agree with your points and thank you for

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plays in morbidity for diabetics. We don’t want to burden an increasing population who

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may not have access to drugs, you know, or have delayed access to treatments because

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we are overly focused on this risk. When I looked at this question and I thought, ‘okay,

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we have this low event rate, that’s one question’.

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So what are our populations? What’s our definition of a diabetic? This

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So, cardiovascular risk is very important because we know the part that it

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We have this gap period where we are trying to fit this study into, you

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DR. TEERLINK: So partly in response to Mark’s comments, in direct

discussion of the question, I think the data that’s been presented does give us some good

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