the FDA are mostly in the business of protecting big pharma. simply and seriously. cytodyn cant simply waltz in with 9 years of good data and dominate the HIV market with out a fight. most likely there is no way they can do anything without handing it all over to a big pharma. no, cytodyn does not have strong evidence. not the only reason but one reason is amarex sabotage. another reason is the FDA refusing an EUA for covid, for a drug they were very familiar with, and had ample belief that the safety record was way past the line of acceptable. no reason for them not to grant that in the first place. the EUA and subsequent patient success rate would have knocked remdesivir out of the game completely, cant have that.
the FDA has blocked this at many junctions, and now the case against nader is another black mark that may result in the hold becoming permanent. bravo.