NP should take on an outside FDA consultant, someone whose job it is to present drugs to the FDA for approval. They don't even have to be part of CytoDyn.
The same for Brazil, a Brazilian consultant who helps with approval of LL, There have to be people who do this for a living and we only have ONE drug, LL.
Same for Canada, same for UK, same for Philippines. I would have hired the FDA guy back last April. Delegate this to the experts.