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because here we have point estimates that are actually in a good direction. So it’s sort of

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reasonable to ask the question that way. Asking the question even the way you did, I

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must say and, you know I would ask others on the panel, I am not aware of a drug that we

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know the risk only emerges in a high risk population. That’s to say assuming that you

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really knew what the risk was in the lower risk population. The problem being, do you

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have enough events to count? That’s the critical thing. If you had enough events to

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count and you knew that it was no risk in a low risk population but the risk emerges in a

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high-risk population, I am not aware of that.

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any drugs where there is a lower risk in one population and a higher risk in a high

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population. What about no risk, no statistically significant risk or signals in the low risk

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population?

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maybe somewhat reassuring is the fact that there aren’t either any pre-clinical signals or

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at least it doesn’t look like there is any off target issues there, which should be the same

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in both the lower risk, intermediate risk and higher risk patient populations. So barring, I

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mean there may be some unknown off target effect here, but the biology would suggest

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and what the Sponsor has shown is that there really isn’t any other pre-clinical signal that

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would suggest that there would be a differential effect in perhaps the higher risk

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population. I don’t know of any example that you are looking.

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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

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different effect in that different risk population?

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DR. BURMAN: Thank you. Other comments? Dr. Veltri.

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DR. VELTRI: I agree with Marvin on this one. I think what is also

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DR. BURMAN: Can I ask, you had mentioned that you don’t know of

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