assure you that I have used say the glitizones and I have never seen anybody have a heart
attack or an adverse cardiac event, which of course is exactly what we are addressing
here today. So what are the options for a drug, which obviously does something for
blood sugar, and in which you cannot define an adverse cardiac event, and yet you may
not have enough data to define it? What are the options in terms of the FDAs dealing
with this drug? I am not sure I quite hear that.
understanding that glycemia control is important, these therapies have a benefit with
respect to controlling diabetes, now the next question is, if that has been established for
us, and I know that is not on the table to discuss here, is that whether or not the quality of
the data that they have here will address that cardiovascular risk goalpost?
give my recollection of the advice we heard about evaluating cardiovascular risk. I am
going to qualify that by saying when it's my recollection, I remember quite clearly
everything I did in high school. I remember everything I have done in the last fifteen
minutes but everything in between is sort of a blur to me. So there may be others that
were at that meeting that have a little different impression but I will give you my
impression. So what the committee was trying to do is to say, we need to have some sort
of balance where we at least know we have some comfort that there won't be a
cataclysmic MI result from a drug. Recognizing that to get definitive data would take
DR. ROSEBRAUGH: So, let me just kind of take us back and at least
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are other programs who had already initiated phase 2, phase 2I are very much well
DR. BURMAN: Thank you. Dr. Levitsky.
DR. LEVITSKY: So as a pediatric endocrinologist, once again I can
We recognize that that is a difficult task before you, but if there is an