(Total Views: 987)
Posted On: 09/11/2020 1:19:59 AM
Post# of 153903
Re: Riztheinvestor #55230
PDUFA Date for HIV review for approval
Cytodn will not have a PDUFA date yet as the FDA has not accepted to file the BLA application. NP stated the objective of the FDA meeting was "hopefully get to discuss that also with the FDA as we are submitting all of CD-03 monotherapy data to the FDA, to have a complete submission and get a PDUFA date" So they are trying to get the FDA to accept the BLA for both combo and mono therapies given they are now submitting the data from the mono trial.
Once the BLA is accepted to file Cytodyn will get a target PDUFA date. Likely best case for approval for HIV is ~4 months assuming the review is expedited, ~8 months if it is not.
Cytodn will not have a PDUFA date yet as the FDA has not accepted to file the BLA application. NP stated the objective of the FDA meeting was "hopefully get to discuss that also with the FDA as we are submitting all of CD-03 monotherapy data to the FDA, to have a complete submission and get a PDUFA date" So they are trying to get the FDA to accept the BLA for both combo and mono therapies given they are now submitting the data from the mono trial.
Once the BLA is accepted to file Cytodyn will get a target PDUFA date. Likely best case for approval for HIV is ~4 months assuming the review is expedited, ~8 months if it is not.
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