presentation now, which applies to both days. Then the applicants will each have a
chance on each day to present their data and then they will field questions from the
advisory panel. After that you will hear FDA presentations. Today you will hear from
our clinical reviewer, Dr. Naomi Lowy, and our biostatistician, Ms. Joy Mele. Tomorrow
you will hear from our non-clinical reviewer, Dr. Anthony Parella, our clinical reviewer,
Dr. Karen Mahoney, and another biostatistician Dr. Janice Derr.
and specifically to discuss whether there is adequate evidence of cardiovascular safety to
support marketing. Tomorrow, we will turn to Liraglutide and we will ask that exact
same question. Is there adequate evidence of cardiovascular safety to support marketing?
For Liraglutide, there also will be discussion and voting related to non-clinical thyroid C-
cell tumors as well as several cases of papillary thyroid cancer reported in the
development program. That’s all that I will say about those topics for today, we will
revisit them tomorrow.
Advisory Committee Panel to question FDA. There will be an open public hearing today.
There was originally one scheduled for both days but we didn’t receive any speaking
request for day two, so there will be no open public hearing tomorrow. Then both the
applicant and FDA can field questions from the Advisory Panel and then the Advisory
Panel will have their discussion and voting.
The objective for today’s meeting is, as I said, to discuss Saxagliptin
The agenda for both days is quite similar. You are hearing my
After the FDA presentations there will be opportunity again for the
glucose control in diabetes. To do this, we first need to speak about GLP-1 (Glucagon-
like peptide-1). This is a hormone that’s released from the small intestine during meals.
Let’s turn briefly to the mechanism by which these two therapies improve
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