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Replies to #42595 on Biotech Values
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DewDiligence

03/01/07 3:04 AM

#42596 RE: p3analyze #42595

>Was the protocol amended and re-spa'd?<

Yes.

>could you cite a press release on that—I couldn't find anything on its website.<

The change was first disclosed on GPCB’s 3Q05 CC on 11/3/05 and I mentioned it on this board the next day (#msg-8361580). I don’t know if it was ever reported via a PR. Regards, Dew
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p3analyze

03/01/07 3:05 AM

#42597 RE: p3analyze #42595

2-week median difference may not capture the exaggerated KM curve separation due to fast placebo arm drop-out. Similar to Panitumumab, but at least there Amgen had independent review and radiological events only. How could an independent panel review pain- something so subjective?

What are the post-approval committment - demonstrating OS in this trial or is it currently enrolling another Phase III maybe in the first-line in case the OS fails?