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the situation it’s pretty consistent with what our committee discussed last summer that

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this evidences is sufficient given the limitations to meet those requirements.

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or the July meeting, and I think everything was done according to those

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recommendations. The signal is low for the question that’s asked, the answer I think is

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yes. I don’t see how you can come around it with the way the question is actually

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worded, if you want to add to the question, you can come up with a no answer, but the

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way the question is worded, it should suggest “Yes” based on what we had this summer

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with a very low signal, a low cardiac signal does not need further investigation.

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comments that were made by two diabetic individuals today about the need for new

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diabetic, anti-diabetic therapies and I think this agent has promised to differentiate itself,

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specifically in getting glycemic control with potentially avoiding hypoglycemia, although

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I stress that the Sponsor didn’t really show that, but there are some promise to that effect,

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Scribes, LLC Toll Free 1-800-675-8846 www.scribesllc.com

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agreeing with the previous comments, and I think the Saxagliptin was caught in the

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interregnum between the former cardiovascular requirements and the new publication of

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guidelines in December 2008, and any effort to assess data in such a study will

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intrinsically have flaws and we’ve taken those into account to the best way we can.

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ruled out 1.8, again I don’t think that’s the right way to phrase it, but overall, I think it

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certainly convinced me that there is not big harm.

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DR. BURMAN: Thank you. Ken Burman I voted yes with a comment

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DR. FLEGAL: I voted yes, and I also agree that within the limitations of

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DR. PROSCHAN: I voted yes also. I think that there is no question they

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DR. HENDERSON: I voted yes with a second to Dr. Teerlink’s concerns

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about labelling.

DR. KONSTAM: I voted yes. Actually I first wanted to just bring out the

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