because here we have point estimates that are actually in a good direction. So it’s sort of
reasonable to ask the question that way. Asking the question even the way you did, I
must say and, you know I would ask others on the panel, I am not aware of a drug that we
know the risk only emerges in a high risk population. That’s to say assuming that you
really knew what the risk was in the lower risk population. The problem being, do you
have enough events to count? That’s the critical thing. If you had enough events to
count and you knew that it was no risk in a low risk population but the risk emerges in a
high-risk population, I am not aware of that.
any drugs where there is a lower risk in one population and a higher risk in a high
population. What about no risk, no statistically significant risk or signals in the low risk
maybe somewhat reassuring is the fact that there aren’t either any pre-clinical signals or
at least it doesn’t look like there is any off target issues there, which should be the same
in both the lower risk, intermediate risk and higher risk patient populations. So barring, I
mean there may be some unknown off target effect here, but the biology would suggest
and what the Sponsor has shown is that there really isn’t any other pre-clinical signal that
would suggest that there would be a differential effect in perhaps the higher risk
population. I don’t know of any example that you are looking.
DR. KONSTAM: I don’t actually. Here, again, we will come back
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guess it’s worth knowing I guess at least, you know, it’s worth asking, will it have a
different effect in that different risk population?
DR. BURMAN: Thank you. Other comments? Dr. Veltri.
DR. VELTRI: I agree with Marvin on this one. I think what is also
DR. BURMAN: Can I ask, you had mentioned that you don’t know of