Sunday, June 28, 2020 1:46:44 PM
" Q: How long does the drug approval process take?
A: The 1992 Prescription Drug User Fee Act (PDUFA) established a two-tiered system – Standard Review and Priority Review.
Standard Review is applied to a drug that offers at most, only minor improvement over existing marketed therapies. The 2002 amendments to PDUFA set a 10 month goal for a standard review.
Priority Review designation is given to drugs that offer major advances in treatment, or provide a treatment where none existed. The goal for completing a Priority Review is six months.
For more information, please see PDUFA Performance Reports and Fast Track, Accelerated Approval and Priority Review ".
https://www.fda.gov/drugs/special-features/frequently-asked-questions-about-fda-drug-approval-process#4
NWBO looks like a priority review, don't you think so ?
GLTU
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