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Posted On: 10/19/2020 2:38:53 AM
Post# of 155048
Re: chuckles759 #61830
That 700mg dosing information requested from HIV trials is exactly that, IMO... Not telegraphing the FDA's ultimate decision, but an insurance against having success with CV19 @700mg and not enough data to justify it's use. It did hold up the HIV BLA but if we need 700mg for CV19, it will be useful
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Remember the FDA pushed for 700mg dosing information to be included in the HIV BLA? What dosing are they giving the COVID Phase 2/3 S/C patients...hmmmmm... And, CytoDyn is already in the CBER process for the HIV BLA which the CTAP program hands applicants off to.
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