Clinical Trial

CytoDyn, Inc.

Study Design CYT-08-01
Single Infusion
Phase	Purpose	Method	N	Endpoints
I	Safety of New Batch of Cytolin®	Dose Escalation	12	Viral Burden CD4+ T Cell Count
IIA	Proof of Principle	Randomized, Double-Blind, Placebo Controlled	25	Viral Burden CD4+ T Cell Count Cutaneous Anergy

Benchmark	Some Factors That Can Cause Delays^†
Patient Outreach	Manufacturing Delays Documentation Delays IRB Delays Delays in Regulatory Review or Approval Force Majeure
Dose First Patient	Fill and Finish Delays Slower Than Expected Patient Enrollment Force Majeure
Lock Database ─ Begin Statistical Analysis	Slower Than Expected Patient Enrollment Clinical Hold Laboratory Error Protocol Deviation Force Majeure
Release Final Report	Additional Stratification Required Computer Hardware or Software Malfunction Force Majeure
†There are other factors, known and unknown, such as unexpected financial hardships, that can cause delays.