Any additions or modifications to that brief summary?
Okay, then let’s go to Question No. 3
Question No. 3:
The Saxagliptin trials included a 24-week, short-term, double-blind period
are uncomfortable with the post-hoc adjudication, which really is, the company is caught
in between the regulation. So both the FDA and the company have done a fantastic job
of trying to work out a system that helps determine whether there is an increased
cardiovascular risk and all of us are uncomfortable with the data as it is. I think given the
circumstances we agree that it’s the best way it can be done and that there are some
suggestions, as John had mentioned and Mike had mentioned, for future trials. There
seem to me to be minor modifications because the data in most of these trials have
already been collected.
followed by a long-term, double-blind period. Patients entered the long-term period if
they completed the short-term period or if they were discontinued from the short-term
period due to inadequate glycemic control. Patients who had entered the long-term
period because of inadequate glycemic control during the short-term period were
administered open-label rescue medications. Please discuss whether this trial design
affects interpretation of cardiovascular results for the short-term period and for the
combined short-term and long-term periods.
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DR. BURMAN: Any other comments on this particular issue?
Then let me try to summarize this issue from part two and that is, all of us