(Total Views: 463)
Posted On: 08/27/2020 3:15:28 PM
Post# of 149733
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?
(0)
(0)Scroll down for more posts ▼
