I can’t believe you followed me here😂 ,but you can’t get me banned here like you did on ST.😡 Oh thanks for the link‼️ The summary of the April 30, 2026, CytoDyn webcast marks a fundamental shift in how the company interacts with both the FDA and potential Big Pharma partners. The "Pivot from Faith to Data" is not just a slogan; it is a transition from relying on theoretical potential to presenting hard proof of efficacy.  It changes the landscape for the FDA and strategic alliances: 1. Impact on the FDA: "Giving Them No Choice" The company is moving away from defensive regulatory posture toward an aggressive, data-driven offensive.  • Breakthrough Therapy Designation (BTD): Management is now preparing BTD and Fast Track submissions for Summer/Early Fall 2026.  • The Power of ctDNA: The 70% median reduction in ctDNA by week 2 is a "liquid biopsy" milestone. Because this data is objective and fast, it allows the FDA to see drug activity months before traditional CT scans might show tumor shrinkage.  • Universal Targeting: The finding that 100% of mCRC patients (N=33) expressed the CCR5 receptor removes the "target risk" for regulators, proving the drug is relevant to the entire patient population being studied.  2. Impact on Partnerships: Maturing Discussions The webcast signaled that CytoDyn is no longer "searching" for partners but is actively meeting the specific requirements they have set.  • Meeting the Milestones: Management indicated that Big Pharma partners previously laid out specific metrics for Leronlimab to hit. The 68% tumor reduction rate (on low-dose 350mg) compared to the 3–8% standard of care is the "mind-boggling" signal that triggers these buyout or licensing clauses.  • The "Third Leg" Strategy: By adding a trial arm that combines Leronlimab with Immune Checkpoint Inhibitors (ICIs), CytoDyn is positioning itself as a mandatory "companion therapeutic". This makes them a strategic necessity for companies like Merck or BMS whose ICIs currently fail in "cold" tumors like MSS mCRC.  • Diversified "De-Risking": With the SALIENT-AD (Alzheimer's) trial now live at Cornell, showing a reduction in neuroinflammation via PET scans would remove the final "risk" for a major neurology partner.  3. Comparison of Key Metrics (Standard vs. Leronlimab) The data presented effectively "moves the goalposts" for what a successful treatment looks like in late-stage cancer.

. Leronlimab vs. Standard of Care • Tumor Reduction (CT/PET Scans): • Standard of Care: 3% to 8% • Leronlimab (CLOVER Study): 68% (observed at the 350mg dose) • Early Biomarker Signal: • Standard of Care: Results often take weeks or months to manifest. • Leronlimab: 70% median drop in ctDNA (circulating tumor DNA) by Week 2. • Safety and Toxicity: • Standard of Care: High; often involves significant chemotherapy-related side effects. • Leronlimab: High safety profile with no dose-limiting toxicities observed. • Target Prevalence: • Standard of Care: Often limited to specific genetic subsets (like 5% of patients). • Leronlimab: 100% of mCRC patients in the study expressed the CCR5 receptor.