At first this 3rd party audit sounded like yet another time delay step in getting the BLA done. I did not think it was a bad idea, but I was hoping it would already have been done or unneeded to finish the BLA. Now I realize how important this could be. I would assume the FDA seeing that a 3rd part has already reviewed the bla that their job is much easier. I would think reviewing a bla that has issues is more time consuming because the issues need to be documented and decided if they are significant enough to stop and have Cytodyn fix them. Now, they likely can breeze through the bla with confidence the issues are already fixed. The fda process once they get the bla might go much faster than 6 months.

The point about legally establishing that Amarex really did not do there job is some thing I completely missed. The settlement of this once presented might be enough to pay for the Nash and cancer trials.