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had which was, you know, that really it’s more than just that we are not seeing an

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increase in events in the treatment group but there is actually, you know, evidence going

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in the other direction. the other issue about the sub-groups, I mean this is just really hard

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to try and figure out, you know, even if your clinical trial enrolls people with heart

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disease, you know, you often don’t have enough to really know whether the effect of the

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drug is different in that group than in the group without heart disease.

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there are lots of options. I think, you know, you could restrict approval to the population

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at hand. That would be one thing you could do. An alternative approach would simply

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to say well, you know, you are approving it for the diabetic population with labelling that

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just simply states that there is not enough data to adequately assess the risk in a higher

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risk population. So the labelling could address this and then depending on what we say

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regarding additional studies, you know, if we are going to say additional studies are

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needed, we could drive that toward a high risk population.

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enough data to be able to see whether there are different effects in different sub-group.

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So it’s just, you know, even if you enrolled some people with heart disease at baseline,

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Dr. Henry pointed out that in the sub-group analysis there is just not

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So there are two bars here for us to grapple with. I think, you know, the question I

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am hearing you ask is if we think it reaches that first bar, would it be approvable for the

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entire population? What else would we need?

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DR. BURMAN: Thank you. Mike one more comment, we will move

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You know, I guess I would turn to the Agency about guidance but I think

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shortly to the question two.

DR. PROSCHAN: Yeah, actually Marvin addressed the first comment I

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