the next 20 minutes, until approximately 10:30 a.m., the Committee will have an
opportunity to ask questions of the Sponsor and we thought the best way to do this is just
open it up to the Committee at the moment and if you have a specific person on the
Sponsor you want to answer that, please direct it, if not just direct it generally. Yes,
if it is all right we are going to have our break now for 15 minutes and then come back
and have questions for the Sponsor and then move on to the FDA discussion. We will try
to resolve the technical issues. On the 15-minute break please remember there should be
no discussion of the meeting topic during the break amongst yourselves or with any other
members, we will resume at 10:05.
consideration, as Dr. Daniels described, the primary objective of that study is to
demonstrate the clinical benefit of Saxagliptin going beyond simple glycemic control. So
our intent is to work with the FDA and perhaps other health authorities to design that
Scribes, LLC Toll Free 1-800-675-8846 www.scribesllc.com
make in the care of patients with type 2 diabetes. We look forward to your discussions
and thank you.
CLARIFYING QUESTIONS FROM THE
COMMITTEE TO SPONSOR
DR. PROSCHAN: This is for Dr. Daniels, who said that there is planned
a clinical trial post marketing. I am wondering what will be the comparator in that trial?
DR. BURMAN: Thank you very much. Because of technical difficulties
DR. BURMAN: All right, why don't we get started? It's 10:10 a.m. For
DR. WOLF: The details of the design of that study are still under