DR. WOLF: It would be hard to make that statement relative to an active
controlled trial. Our statements at the present time are based upon comparison to placebo
Saxagliptin, it does not demonstrate any worrisome trends for hypoglycemia in primarily
placebo-controlled trials. The proper way to assess that is do active control studies. We
currently have an active control study ongoing, a head-to-head study against Sulfonylurea
on top of Metformin and this study is long in duration and is ongoing at this time. So,
one of the reasons that we are conducting the study is to address that very question.
definition of primary MACE, and I just wonder if you could share with us how you came
to it, I guess if I were thinking about it for the first time, I might think along - what I
think was along the lines of thinking that the FDA followed that, let's start with SMQMI
and go from there. You didn't do that and I just wonder if you could tell us how you got
to that primary definition and is it really the first one you tried or, what can you tell us
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because I didn't really see evidence in the data set to support a claim I guess, that you
have less propensity to hypoglycemia than other agents, in the signals that you presented,
there was nothing worrisome about an excess amount of hypoglycemia, but nor was - did
I see any support that you would be relatively less prone to hypoglycemia than other
agents. Is that something you think you can defend based on the clinical data?
DR. KONSTAM: All right. So at this point, it's really hard to make that
statement definitively I guess.
DR. KONSTAM: Okay. The second question I have is about your
DR. WOLF: We agree with your assessment of the current data for