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DewDiligence

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DewDiligence

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Re: bladerunner1717 post# 52747

Sunday, 09/23/2007 9:10:28 PM

Sunday, September 23, 2007 9:10:28 PM

Post# of 252782
Abraxane showed highly statsig superiority to paclitaxel on response rate, which was the primary endpoint of the pivotal trial:

http://www.fda.gov/cder/foi/label/2007/021660s010lbl.pdf (page 7-8)

>>
…patients in the ABRAXANE® treatment arm had a statistically significantly higher reconciled target lesion response rate (the trial primary endpoint) of 21.5% (95% CI: 16.2% to 26.7%), compared to 11.1% (95% CI: 6.9% to 15.1%) for patients in the paclitaxel injection treatment arm… p=0.003.
<<

Tocosol paclitaxel should do fine if it, too, shows superiority to paclitaxel. The debate on this board has been about what will happen if it merely shows non-inferiority.

“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

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