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Re: HDGabor post# 178079

Wednesday, 02/27/2019 7:29:18 AM

Wednesday, February 27, 2019 7:29:18 AM

Post# of 424692
Thanks.

My understanding is that the priority review takes 6 months:

"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)."

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

So lets say the sNDA is submitted mid March. The FDA then have 60 days to decide if its priority review or not which would put the decision around mid May. If it's 6 months then that would mean a decision then by mid-November. If it's standard then that would mean a decision by mid-March 2020.

Of course they are going to seek priority review, its worth a lot of money. I don't personally see any reason why they wont get it.
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