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task at hand - the careful consideration of the data before the committee as well as the

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public comments. The format for this afternoon will be as follows: We will ask the

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Sponsors to come up in a minute to bring us up-to-date on the issues regarding the

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questions from Dr. Teerlink and the committee this morning regarding chronic renal

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failure. Then we will open the floor for a period of time for further discussions for the

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FDA and the Sponsor. Then we will move right on for the committee to discuss the

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issues at hand in an organized fashion. Would the Sponsor please come up as they

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requested and we have requested them to bring us up-to-date on chronic renal failure

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issues?

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DR. BURMAN: Thank you very much. I believe that closes the OPH

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session and the Open Public Hearing portion of this meeting is now concluded and we

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questions that we wanted to clarify that we worked on during the break. We were asked

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about signals for a skin cancer either in the non-clinical or the clinical environment. We

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have performed two long-term non-clinical carcinogenicity studies, in those studies, and

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they performed at high multiples of the clinical exposure. We saw no signals for increase

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in cancers including skin cancer of those non-clinical trials. During the break we looked

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DR. WOLF: We will respond to that question. There were a few other

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people with pre-diabetes, thank you so much for your work on making diabetes easier

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for patients and for families. Thank you.

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QUESTIONS FROM COMMITTEE TO

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SPONSOR AND FDA

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DR. BURMAN: The committee will now turn its attention to address the

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will no longer take comments from the audience.

(The Open Public Hearing Session closed.)

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