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Posted On: 08/27/2020 3:15:28 PM
Post# of 153905
Latane,
I apologize as I could certainly be wrong. The dates of the BLA are not something I have tracked as closely as I should.
Having read other posts that seem to have a better command of that knowledge, I believed, again perhaps inappropriately, that the PDUFA date could be six months after the issues of needles and additional safety data are settled.
I understood that the six month expedited approval timeline begins once the application is considered complete and accepted by the FDA. The clock I believe is reset from the April 27 filing to whenever the the FDA agrees that its requests for additional information from Cytody have been satisfied.
Anyone else know more precisely?
I apologize as I could certainly be wrong. The dates of the BLA are not something I have tracked as closely as I should.
Having read other posts that seem to have a better command of that knowledge, I believed, again perhaps inappropriately, that the PDUFA date could be six months after the issues of needles and additional safety data are settled.
I understood that the six month expedited approval timeline begins once the application is considered complete and accepted by the FDA. The clock I believe is reset from the April 27 filing to whenever the the FDA agrees that its requests for additional information from Cytody have been satisfied.
Anyone else know more precisely?
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