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  4. CytoDyn Inc (CYDY) Message Board

FDA regulations, reserve samples from bioavailabil

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Post# of 155150
(Total Views: 324)
Posted On: 07/15/2025 2:23:44 PM
Posted By: My69z
FDA regulations, reserve samples from bioavailability (BA) and bioequivalence (BE) studies must be retained for at least 5 years following the date the application or supplemental application is approved, or if not approved, 5 years from the completion of the study. This requirement is outlined in 21 CFR § 320.38.

Applicability:
This requirement applies to both approved and unapproved applications, as well as to situations where the study is discontinued or terminated.
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So blood samples must be retained 5 years

Cytodyn page 10 of human trial results:

"After Leronlimab initiation, frequencies of CCR5+CD4+ T cells circulating in the peripheral blood in Leronlimab-treated participants were statistically higher than in untreated participants (Figure 5C).

Thus, the longitudinal CD4+ T cell
CCR5 RO in Leronlimab-treated participants and lack of measurable CCR5 RO in Leronlimab-untreated participants demonstrates the robustness and sensitivity of the clinical CCR5 RO assay."
___
Cytodyn has retained Hiv samples for running our CCR5 RO assay test @ all 3 historical dosing levels...

For toxic CD4+ T Cells increase comparisons


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