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drbio45

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drbio45

Re: jshaffer85 post# 847

Thursday, 10/11/2007 8:26:26 AM

Thursday, October 11, 2007 8:26:26 AM

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I would like to make the point that odac had 3 hours to look at data that the fda has had over a year to review. There was also only one transplant specialist on the panel and he voted to approve the drug.

I am sure that Dr. Pazdur has had time to review the data showing that the treatment failure at 50 days showed that there were 30 treatment failures on placebo and only 18 failure on orbec with a p value of .0515. The panel never saw that data. It was in Dor's briefing document but I am pretty sure the panel never looked at that. they were probably more interested in the idm data
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