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CytoDyn Inc CYDY
(Total Views: 714)
Posted On: 11/02/2020 7:10:01 PM
Post# of 154881
Posted By: havasu78
Re: blafarm #64056
Thanks much, blafarm. When Pourhassan described the problem on the HIV receptor occupancy tests, I thought it must have happened a long time in the past.

I think I understood it that way because CCR5 receptor occupancy testing was not highlighted as a reason for HIV BLA Refuse-To-File letter.

At least I don't remember it that way. I remember the RTF conference call as highlighting two primary factors: vial labelling issues and more nebulous further data requests, but not further testing. I got the impression that the FDA was asking for more data spreadsheets on different topics than CYDY had provided in the BLA filing.

But now I see that the nebulous "more data" needed issue could have been a re-test of CCR5 receptor occupancy.

I thought Pourhassan's diss of Patterson via HIV related CCR5 testing was nothing more than Pourhassan throwing shade at Patterson, and not related to the HIV BLA RTF.

So an excellent question indeed as to what extent CCR5 re-testing will impact HIV BLA.

Probably an excellent question as well for the UK HIV BLA.













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