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Alias Born 07/15/2006

Re: nivasvs post# 13938

Thursday, 09/04/2008 3:22:36 PM

Thursday, September 04, 2008 3:22:36 PM

Post# of 19309
Under Priority Review, the FDA’s target date for action on the BLA is February 7, 2009.

However, since the facilities have already been inspected (as I recall); and since GTCB was submitting an accelerated rolling BLA; then it is not inconceivable that approval may occur much sooner than February, perhaps even in 2008...:)...

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