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Posted On: 11/02/2020 6:32:32 PM
Post# of 154897
Yes, the FDA indicated to Cytodyn that the HIV receptor occupancy tests were unacceptable. Therefore, the tests need to be re-run, which is in-process, but very time-consuming.
CytoDyn asked the FDA if the BLA can be re-submitted without those test results, to accelerate the BLA Acceptance/PDUFA Date process. The intent would be that CytoDyn would submit the receptor occupancy tests afterward, in a staggered manner, as soon as they are completed.
So, I want to learn the FDA's disposition on this topic, as a rejection would clearly add significant time to the BLA re-submission date.
CytoDyn asked the FDA if the BLA can be re-submitted without those test results, to accelerate the BLA Acceptance/PDUFA Date process. The intent would be that CytoDyn would submit the receptor occupancy tests afterward, in a staggered manner, as soon as they are completed.
So, I want to learn the FDA's disposition on this topic, as a rejection would clearly add significant time to the BLA re-submission date.
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