something that there should be more data on, more because it could be that this drug is a
safer drug to use under some circumstances. There wasn’t enough data in terms of that or
and so forth that might make them different from middle-aged patients, so I think that
should also be monitored in a future study.
wouldn’t be fair to apply that rule today, but on the other hand, it isn’t fair to not
insist on getting that type of data in the relatively near future, so that we can be sure that
our optimism about the data that we’ve looked at is, applies across the whole spectrum of
diabetic patients, I’ve been more struck in the last couple of years looking at the results of
ACORD and the VA study and the long-term results of the UK PBS that the
cardiovascular complications are more complex than many of us had thought and that we
just need more data in that area.
that everyone wants good post-marketing studies with the criteria that we mentioned
earlier and I want to congratulate the committee for really doing a good job of walking
the fine line between preserving patient safety and yet trying to move drugs in this
transitional period into the market. I would like to ask if the FDA has any other
comments or questions that they would like to bring up at the present time, No?
Anybody have any other issues?
I also think that the issue of avoiding hypoglycemia is important and
DR. LESAR: I voted no. For many of the reasons that have already been
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discussed and particular the need to study this drug further in patients with high risk.
DR. BURMAN: Thank you. I think this is an easy one to summarize in