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p3analyze

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p3analyze

Re: turtlepower post# 87433

Monday, 12/14/2009 9:31:50 AM

Monday, December 14, 2009 9:31:50 AM

Post# of 257624
IMGN - I would expect if Roche had truly desired a BLA they would have requested a meeting with FDA a long time ago, because I assume Roche has known about the response rate from this single-arm study for quite a while. Yes mature PFS median would help, but it doesn't mean much to the regulators imo.
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