Sajacobs, I transcribed this from Oct 20 CC Q&A
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Posted On: 01/21/2021 3:24:37 PM
Sajacobs,
I transcribed this from Oct 20 CC Q&A:
"What is the status of the HIV BLA to the FDA? What does Cytodyn need to do to complete a successful BLA?
So one of the things that I have said in the past is that data for phase 3 monotherapy that one needed to be compared to the phase three combination therapy and with our new Chief Science Officer, we will be able to go a lot faster and we will be able to give timelines at this time. We're working on all the items that FDA has indicated they want. Somebody told me about Receptor Occupancy. Well, if you don't have that how you going to be able to enroll... I'm sorry to file the BLA. With the receptor occupancy test, we could start the process and go to FDA and say here's our BLA and we would like to ask to give the rest of the Receptor Occupancy test during the review. Obviously we got hurt when our Receptor Occupancy test was rejected by FDA, but we have a way around that we believe to not to slow us down, but yet get it done and we got two companies that are working on that right now."
I transcribed this from Oct 20 CC Q&A:
"What is the status of the HIV BLA to the FDA? What does Cytodyn need to do to complete a successful BLA?
So one of the things that I have said in the past is that data for phase 3 monotherapy that one needed to be compared to the phase three combination therapy and with our new Chief Science Officer, we will be able to go a lot faster and we will be able to give timelines at this time. We're working on all the items that FDA has indicated they want. Somebody told me about Receptor Occupancy. Well, if you don't have that how you going to be able to enroll... I'm sorry to file the BLA. With the receptor occupancy test, we could start the process and go to FDA and say here's our BLA and we would like to ask to give the rest of the Receptor Occupancy test during the review. Obviously we got hurt when our Receptor Occupancy test was rejected by FDA, but we have a way around that we believe to not to slow us down, but yet get it done and we got two companies that are working on that right now."
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