had which was, you know, that really it’s more than just that we are not seeing an
increase in events in the treatment group but there is actually, you know, evidence going
in the other direction. the other issue about the sub-groups, I mean this is just really hard
to try and figure out, you know, even if your clinical trial enrolls people with heart
disease, you know, you often don’t have enough to really know whether the effect of the
drug is different in that group than in the group without heart disease.
there are lots of options. I think, you know, you could restrict approval to the population
at hand. That would be one thing you could do. An alternative approach would simply
to say well, you know, you are approving it for the diabetic population with labelling that
just simply states that there is not enough data to adequately assess the risk in a higher
risk population. So the labelling could address this and then depending on what we say
regarding additional studies, you know, if we are going to say additional studies are
needed, we could drive that toward a high risk population.
enough data to be able to see whether there are different effects in different sub-group.
So it’s just, you know, even if you enrolled some people with heart disease at baseline,
Dr. Henry pointed out that in the sub-group analysis there is just not
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So there are two bars here for us to grapple with. I think, you know, the question I
am hearing you ask is if we think it reaches that first bar, would it be approvable for the
entire population? What else would we need?
DR. BURMAN: Thank you. Mike one more comment, we will move
You know, I guess I would turn to the Agency about guidance but I think
shortly to the question two.
DR. PROSCHAN: Yeah, actually Marvin addressed the first comment I