the situation it’s pretty consistent with what our committee discussed last summer that
this evidences is sufficient given the limitations to meet those requirements.
or the July meeting, and I think everything was done according to those
recommendations. The signal is low for the question that’s asked, the answer I think is
yes. I don’t see how you can come around it with the way the question is actually
worded, if you want to add to the question, you can come up with a no answer, but the
way the question is worded, it should suggest “Yes” based on what we had this summer
with a very low signal, a low cardiac signal does not need further investigation.
comments that were made by two diabetic individuals today about the need for new
diabetic, anti-diabetic therapies and I think this agent has promised to differentiate itself,
specifically in getting glycemic control with potentially avoiding hypoglycemia, although
I stress that the Sponsor didn’t really show that, but there are some promise to that effect,
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agreeing with the previous comments, and I think the Saxagliptin was caught in the
interregnum between the former cardiovascular requirements and the new publication of
guidelines in December 2008, and any effort to assess data in such a study will
intrinsically have flaws and we’ve taken those into account to the best way we can.
ruled out 1.8, again I don’t think that’s the right way to phrase it, but overall, I think it
certainly convinced me that there is not big harm.
DR. BURMAN: Thank you. Ken Burman I voted yes with a comment
DR. FLEGAL: I voted yes, and I also agree that within the limitations of
DR. PROSCHAN: I voted yes also. I think that there is no question they
DR. HENDERSON: I voted yes with a second to Dr. Teerlink’s concerns