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Posted On: 05/20/2020 7:35:40 PM
Post# of 151605
It appears that a 6 month review is not guaranteed yet.
per the May 11th PR
"the Company plans to request a priority review for the BLA. A priority review designation, if granted, means the FDA’s goal is to take action on the application within six months of receipt (compared with 10 months under standard review)."
per the May 11th PR
"the Company plans to request a priority review for the BLA. A priority review designation, if granted, means the FDA’s goal is to take action on the application within six months of receipt (compared with 10 months under standard review)."
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