even though they are - when referred to placebo control, it's actually add-on. So they
were standard background therapy. In our guidance, we do not specify what that
comparator should be and we are actually very specific in terms of assessment risk as to
all comparators as you will hear in the subsequent discussion. It's very difficult to define
or state up front what that comparative must be. It has the complexity and I think a lot of
the diabetologists and endocrinologists around the room here could speak to that as well
as the complexity of the disease will make it very difficult to say that this must be the
comparator for which, and overtime to do a long-term study to assess cardiovascular risk,
it's also going to be multiple therapies that will eventually be added on to both groups.
relative to. I mean apparently it seems that sometimes when you compare to an active
comparator, it actually comes out better than when you compare it to the placebo and,
given that many of the drugs that have already been approved were approved on a basis
of HbA1c, it's possible that those drugs also have cardiovascular harms. So showing that
it's better than one of the approved drugs might not be saying that much. So does the
FDA have a position on what that comparison should be, what that active comparator
should be for example?
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DR. PARKS: I think it is important to point out that in this program here
mean I guess the deal is you get more events, you take the non- specificity, you try to
reach some reassurance and you see what you get.
DR. BURMAN: Thank you. Dr. Proschan.
DR. PROSCHAN: I guess one of the difficult issues is, what the 1.8 is
DR. BURMAN: Thank you. Dr. Teerlink, did you have another