(Total Views: 528)
Posted On: 09/07/2020 1:22:19 PM
Post# of 155256
There might be some confusion regarding the Multidisciplinary Review.
My understanding is the function of this review is to provide CytoDyn with confidence that a revised BLA filing has all of the required data and formatting for re-submission.
The goal is to prevent CytoDyn from receiving another RTF 60-days after the re-submission of the revised BLA.
The 30+ day Multidisciplinary Review does not end with a BLA acceptance, it does not end with a PDUFA date, and it does not end with a BLA approval. After the review is completed, CytoDyn receives the review feedback, makes any necessary changes, and then resubmits the BLA.
And according to my understanding, the approval clock is reset to zero.
So, if the above understanding is correct, I don't see how the Multidisciplinary Review adds any value (real or optical) to a COVID EUA.
My understanding is the function of this review is to provide CytoDyn with confidence that a revised BLA filing has all of the required data and formatting for re-submission.
The goal is to prevent CytoDyn from receiving another RTF 60-days after the re-submission of the revised BLA.
The 30+ day Multidisciplinary Review does not end with a BLA acceptance, it does not end with a PDUFA date, and it does not end with a BLA approval. After the review is completed, CytoDyn receives the review feedback, makes any necessary changes, and then resubmits the BLA.
And according to my understanding, the approval clock is reset to zero.
So, if the above understanding is correct, I don't see how the Multidisciplinary Review adds any value (real or optical) to a COVID EUA.
(1)
(0)
