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Re: iwfal post# 115025

Thursday, 02/17/2011 8:58:33 PM

Thursday, February 17, 2011 8:58:33 PM

Post# of 257288
I'd agree pain improvement data itself isn't impressive because it wasn't measured in meaningfully comparable way. Other agents can reduce pain as well.

The question is whether FDA will be moved by combination of pain improvement and bone scan for relatively quick approval.

Many questions are still out there, can only be answered with more data. The positive is data has held up well with slightly larger sample size.

What I don't like is they rush too much. Now they are talking about two dosages for phase III. I am not sure how much they have studied the lower dose in PC. This happenned in GBM when original dose schedule 175mg was too much, had to be studied again for 125mg.

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