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Re: p3analyze post# 3360

Thursday, 05/10/2007 6:38:28 AM

Thursday, May 10, 2007 6:38:28 AM

Post# of 12660
There are only two possible ways that DNDN could get Provenge to market this year, but only if enrollment is completed in the next month:

-first step would be to persuade the FDA to give them a free look at 9902B

-next step would be to look at the overall survival curves, see if they are significant...pretty tough, because there will be many recently enrolled patients who would have to be censored...but maybe there will be some median survival benefit seen

-another option is to look at the ttp data...unblind it in late Aug, ten weeks after enrollment completion, hope it's stat sig, then try for Accelerated Approval on the ttp endpoint, send it to FDA before end of Oct, hope FDA grants Class 1 response, two-month review

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