Biotech Values

[willyw]

The exact PDUFA date is not disclosed, but it should be on or about 8/2/17.

http://www.fda.gov/ForPatients/Approvals/Fast/ucm405405.htm

"A Priority Review designation means FDA’s goal is to take action on an application within 6 months (compared to 10 months under standard review)."
(also...) "FDA informs the applicant of a Priority Review designation within 60 days of the receipt of the original BLA, NDA, or efficacy supplement."

So I guess I was thinking that the 6 months would go back to the December 19, 2016 Abbvie NDA.

Likewise.... since for G-1 they were already getting a speedier evaluation, wouldn't that suggest for G-1 a june approval? Is it possible the other genotypes could be approved on the same timeline now as G-1 for G/P?

Where am I making my mistake?