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DewDiligence

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Re: mskatiescarletohara post# 27880

Sunday, 04/30/2006 11:18:28 AM

Sunday, April 30, 2006 11:18:28 AM

Post# of 253651
VRTX – My guess is accelerated given guidance recently stated by the company, they didn't come right out and state accelerated, however in viral indications if Phase II supports dosing, and pivotal 24 week data is available the FDA can or will consider accelerated approval.<

Josh Boger is considered by many to be a promotional CEO, as biotech CEOs go, and even Boger has not touted the idea of accelerated approval for VX-950 based on phase-2 data in any presentation I’ve heard.

I suspect that accelerated approval will be very hard to pull off unless VX-950’s safety profile is absolutely pristine.

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

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