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jq1234

02/17/11 8:58 PM

#115042 RE: iwfal #115025

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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AlpineBV_Miller

02/18/11 7:38 AM

#115089 RE: iwfal #115025

Scher pointed out that no drug with a OS benefit in PCa has a pain benefit on its label. This includes cabazitaxel and docetaxel.