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Re: genisi post# 116857

Thursday, 03/24/2011 12:19:48 AM

Thursday, March 24, 2011 12:19:48 AM

Post# of 252334
Elvitegravir met the NI threshold with plenty of room to spare:

http://finance.yahoo.com/news/Phase-III-Clinical-Trial-of-bw-708388788.html?x=0&.v=1

The primary endpoint analysis indicated that 59.0 percent of patients in the elvitegravir arm compared to 57.8 percent in the raltegravir arm (95% CI for the difference: -6.0% to +8.2%) achieved and maintained a viral load of less than 50 copies/mL through week 48. The predefined criterion for non-inferiority was a lower bound of a two sided 95% CI of -10%.

By prior agreement with the FDA, this is the only phase-3 study GILD needs to obtain approval for Elvitegravir—provided, of course, that there are no safety problems.

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