>> 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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