Again, read the FDA RTF letter. The letter directed to Amarex as CytoDyn's regulatory agent, talks among other things items that they must have had because they were in one section of the filing, but Amarex failed to put in another section in which it was required, too.
Not going to analyze the letter for you because another lawyer Aaron Denenberg has done a superb job of analyzing the first several pages and he is posting it to various stock boards as he goes along.
I would read the FDA RFT letter and his analysis before commenting further if you don't want some of the non-lawyers on this board showing you up.