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ThomasS

09/04/08 8:05 AM

#13939 RE: nivasvs #13938

Good news, as expected.
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croumagnon

09/04/08 3:22 PM

#13954 RE: nivasvs #13938

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...:)...