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would echo the fact that a post-marketing study should include a longer trial with higher

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risk patients and assessing many of the issues we discussed previously not only

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cardiovascular risk and events in a codified manner. Also take high risk patients, assess

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other factors such as lymphocyte count, platelet count, look at pancreatic function and

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look at skin lesions potentially among some of the other issues that have been discussed.

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I voted no as well because our primary goal is to protect the patient population, I just

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don’t think there is enough data in the studies that have been performed thus far to be

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absolutely certain that there is no risk or very little risk to many of the population studied.

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longer term trial regardless of the drug, I mean I just think it’s a scary proposition

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here because of the fact that the adjudication of events, there is enough uncertainty there

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to make me feel even more like I do want to do a longer term trial and perhaps it would

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be nice to enroll people with coronary disease, so we can get evidence on that.

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estimates are favorable, this is very encouraging, but there is a small number of events

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and lack of adjudication. So I don’t think we really have enough data to be sure about

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this.

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DR. FLEGAL: I also voted no for the reasons everybody stated, the point

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DR. BURMAN: I voted no. I agree with the previous comments and

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complement the Sponsor and the agency and the work they’ve done in trying to evaluate

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this data and see if we could pull out any kind of cardiovascular safety data.

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DR. WYNE: I voted no. I would like to, as people said earlier really

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DR. FELNER: I voted no and mainly driven by the comments from Dr.

Teerlink and Dr. Wyne.

DR. LEVITSKY: I voted no and I agree with everyone, so I will say no

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more.

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