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Re: NP1986 post# 125548

Wednesday, 08/24/2011 10:12:54 AM

Wednesday, August 24, 2011 10:12:54 AM

Post# of 257268

I don't think it is likely they will accept bone scan results as the primary endpoint of the study.



I agree with that - I was suggesting a co-primary of bone scan plus pain reduction. If the bone scan results are proved to be "real" - in other words there is real healing of these lesions, then I don't see why that is any less significant than a RECIST tumor response, and here you would be demonstrating clinical benefit in terms of pain reduction.

Not sure what the skeletal event-rate is in the untreated population if they have to fall back on that - at some point it might be easier to just go for overall survival as you suggest.

Peter

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