FDA regulations, reserve samples from bioavailabil
Post# of 155150

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."
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Cytodyn has retained Hiv samples for running our CCR5 RO assay test @ all 3 historical dosing levels...
For toxic CD4+ T Cells increase comparisons

