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Something that the panel members need to keep in mind as Dr. Joffe mentioned in his

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introductory statement is that these are programs that were all ready underway;

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completed at the time the guidance was finalized. So, knowing that limitation, there is

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not a whole lot you can do at this point. Going forward, the guidance clearly specifies

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that there should be an attempt to enroll more patients where you can capture these events

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and perhaps generalizability to the population will be to prescribe these drugs.

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proceed with my thinking and I think may be the FDA can help me figure out about this.

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In the guidance document, I think it very appropriately suggests that you have to do these

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in high-risk patients and so you can assess the effect in its cardiovascular events. If we

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get, I mean it becomes an issue of generalizability. So what kind of guidance can you

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give us if we believe that the population in which the drug is studied doesn’t have

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relevance to the question of cardiovascular risk? How are we to apply data from this data

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set to another, to the issue of cardiovascular risk?

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think what we are asking and we will want you folks to help us with during the

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discussion part is whether you think having an MI in somebody that has only had

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diabetes for three or four or five years, is different than an MI in somebody that has had it

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for 10 or 20 or 30 years. We need your help with that, that’s part of the question.

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DR. TEERLINK: Maybe I can, I am just struggling a bit with how to

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DR. PARKS: I guess you’re touching on point discussion number one.

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standard of protecting the public health against these potential complications for agents

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that were already in that process or how we are suppose to balance those?

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DR. TEERLINK: So are you suggesting that we apply a different

DR. ROSEBRAUGH: Yeah. I don’t think we’re suggesting that at all, I

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