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presentation now, which applies to both days. Then the applicants will each have a

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chance on each day to present their data and then they will field questions from the

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advisory panel. After that you will hear FDA presentations. Today you will hear from

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our clinical reviewer, Dr. Naomi Lowy, and our biostatistician, Ms. Joy Mele. Tomorrow

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you will hear from our non-clinical reviewer, Dr. Anthony Parella, our clinical reviewer,

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Dr. Karen Mahoney, and another biostatistician Dr. Janice Derr.

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and specifically to discuss whether there is adequate evidence of cardiovascular safety to

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support marketing. Tomorrow, we will turn to Liraglutide and we will ask that exact

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same question. Is there adequate evidence of cardiovascular safety to support marketing?

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For Liraglutide, there also will be discussion and voting related to non-clinical thyroid C-

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cell tumors as well as several cases of papillary thyroid cancer reported in the

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development program. That’s all that I will say about those topics for today, we will

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revisit them tomorrow.

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Advisory Committee Panel to question FDA. There will be an open public hearing today.

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There was originally one scheduled for both days but we didn’t receive any speaking

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request for day two, so there will be no open public hearing tomorrow. Then both the

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applicant and FDA can field questions from the Advisory Panel and then the Advisory

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Panel will have their discussion and voting.

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The objective for today’s meeting is, as I said, to discuss Saxagliptin

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The agenda for both days is quite similar. You are hearing my

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After the FDA presentations there will be opportunity again for the

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glucose control in diabetes. To do this, we first need to speak about GLP-1 (Glucagon-

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like peptide-1). This is a hormone that’s released from the small intestine during meals.

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Let’s turn briefly to the mechanism by which these two therapies improve

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