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biomaven0

08/24/11 10:12 AM

#125573 RE: NP1986 #125548

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