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EricVan

05/12/07 7:25 PM

#3519 RE: p3analyze #3518

Hi, was wondering if u could help me a bit with this stock..I heard the drop is due mainly because of the FDA delayed in approval?! Am I correct? thanks
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iwfal

05/13/07 12:03 AM

#3523 RE: p3analyze #3518

I am slightly confused by the discrepancy between what Gold said on the CC, and what Mark did on the Adcom.

Both said Gleason score (<=7 vs >=8) is a stratification factor, so it can't be used as a covariate.

In the AdCom, Mark said in addition, they stratify for bisphosphate use and bony metastases was another stratification factor, but in Gold's response to Duncan, he seem to indicate that the number of bone mets will be used as a covariate in the model.


No inherent reason you can't use a stratification variable as a covariate in a Cox Regression. E.g. you might stratify by Gleason <=7 or G>7 and then run a Cox regression using Gleason score with an assumption of linearity effect of G on life expectancy. But that said I have never seen a crisp story from any company about exactly what kind of analysis they were going to run. So no surprise that we might hear contradictory things.