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Replies to #12610 on Biotech Values
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DewDiligence

06/27/05 7:45 PM

#12618 RE: masterlongevity #12610

More on the Evizon timeline (from the Yahoo board):

>>
Re: Size, endpnt, stat threshold, timeline
by: DewDiligence
06/27/05 07:36 pm
Msg: 73422 of 73423

>>Thanks but its hard for me to believe that the FDA will not move this along before 2009. I think there is going to be alot of political pressure applied to use common sense in this critcal trial as well as others.<<

Hogwash.

Two-year trials treat patients for two years, and you can’t treat patients until you enroll them. Figure about 18 months from now until both phase-3 trials reach full enrollment, three months for data analysis at the end of the trials, three months to prepare the NDA (less time than most companies take), and six months for a priority FDA review. That’s 54 months in all, which takes you to the end of 2009 or the beginning of 2010.

[Posted as a reply to: Msg 73421 by civic08801]
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