Yes, because the FDA has been very clear they do n

Yes, because the FDA has been very clear they do not like Cytodyn publicizing fantastic results before they have done there full review and decided on weather to give a BTD. They want to get everything in front of them and do their work without the public telling them what they have already decided. It is not right, the fda must understand the process companies have to go through is way beyond just running a trial with integrity. The money and risk involved keeps the process impossible and too many promising drugs never get anywhere. Leronlimab is one of those drugs that was in that category until Cytodyn bought it. Cytodyn must sell the sizzle on the steak to get the funding to pay for the fda trials. The fda does not like that, they are out of touch. The fact that orphan drug designation, fast track, BTD exist is because the fda can’t figure out how to streamline the process. They are workarounds for their own process. The fact they holdup these very workarounds from the drugs that absolutely deserves them is a farce.

What does Cytodyn do? Follow what the FDA wants and get the result out of them.