The FDA does not hold all the cards. The world of foreign regulators is already questioning the integrity of the FDA because of their approvals of drugs that don’t work. It was always they followed what ever the FDA does, now I’m not so sure. The world is extremely frustrated with their process. The situation is we have cytodyn following the rules, doing everything the fda asks and not getting approvals in the end. Any doctor can look at the data and see without doubt that leronlimab is needed badly.

The news is filled with the unknown of the mutations and if the vaccine works against them. Look at what is happening in Italy, another wave is coming and the FDA knows it. Leronlimab works and is completely independent of what mutations are out there. The data is not just showing benefit, it is showing it works even if the patient is taking SOC, it is not hurting the SOC, it is better on top of SOC, not in comparison to SOC. Doctors are oftentimes in the situation where they need to decide which treatment is better, with leronlimab they can only use it, add it to SOC, use it on any combo of SOC. There is no downside!

If you were Janet Woodcock, would you risk not acting in favor of continued trial that will lead to congressional hearings and most likely getting fired?