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Posted On: 09/01/2020 11:35:47 AM
Post# of 148899
Wasn't this discussed like ten times already? You are absolutely correct...
Recent examples of the process are Zogenix and Bristol-Myers' idecel...
A RTF stops the review process and makes a resubmission necessary.
Type A meeting ----> Resubmission of BLA
> BLA acceptance/another RTF after 60 days
> New PDUFA date (6 months priority review).
CYDY will resubmit the BLA by end of this year, given AMAREX's speed rather later this year, which puts us at 2+6 months from November/December, thus August 2021.
Of course, FDA could finish the review in 4 months or so after acceptance, but I wouldn't bet on it...
Recent examples of the process are Zogenix and Bristol-Myers' idecel...
A RTF stops the review process and makes a resubmission necessary.
Type A meeting ----> Resubmission of BLA
> BLA acceptance/another RTF after 60 days
> New PDUFA date (6 months priority review).
CYDY will resubmit the BLA by end of this year, given AMAREX's speed rather later this year, which puts us at 2+6 months from November/December, thus August 2021.
Of course, FDA could finish the review in 4 months or so after acceptance, but I wouldn't bet on it...
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