I asked ChatGPT today why this process is so slow




The FDA’s slow decision-making on leronlimab is due to several factors:


1. Past Regulatory Issues & Clinical Hold
In March 2022, the FDA placed a clinical hold on leronlimab for HIV and COVID-19 due to concerns over trial data, safety, and manufacturing compliance.
CytoDyn had to address these concerns, which delayed further trials.
In 2024, the FDA lifted the hold for HIV-related research, but approval is still pending further studies.

2. Data Integrity & Trial Design Concerns
The FDA questioned the validity of past clinical trial data submitted by CytoDyn.
The company faced leadership turmoil and SEC investigations over promotional claims, which eroded trust.
The FDA requires rigorous, well-controlled trials before granting approvals.


3. Shifting Regulatory Priorities
The FDA prioritizes drugs with clearer evidence and those that address urgent, unmet medical needs.
Other HIV, cancer, and fibrosis treatments are also being evaluated, meaning leronlimab must stand out to get expedited review.


4. Complex Mechanism of Action
Leronlimab targets CCR5, a receptor involved in HIV, cancer metastasis, and inflammation.
Because it has multiple potential uses, the FDA requires specific, disease-focused trials, increasing the timeline.

5. Need for Additional Trials
While early results for HIV, cancer, and liver fibrosis are promising, the FDA demands more extensive Phase 3 trials to confirm efficacy and safety.
Each new indication (e.g., mTNBC, colorectal cancer, fibrosis) requires separate approvals, further slowing progress.
Bottom Line

The FDA isn't necessarily "slow" but is cautious due to past concerns, trial design flaws, and the need for strong, reproducible data. The process will likely speed up if ongoing trials show clear, positive results and CytoDyn maintains regulatory compliance.