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Re: drbio45 post# 159

Thursday, 05/13/2004 4:09:53 PM

Thursday, May 13, 2004 4:09:53 PM

Post# of 9294
>> You file an nda, it should take 12 months, you are looking at 15 to 18 months if you are lucky.<<

15 to 18?

A BLA priority review is 6 months or less.

The BLA for Erbitux was filed 8/14/03, and the drug was approved 2/12/04 (6 months). The BLA for Avastin was filed 9/28/03, and the drug was approved 2/26/03 (5 months).

If the RIGS BLA review ends up taking 3-6 months, that’s hardly a big deal.

By the way, my question about 3 months or 6 months was rhetorical.


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