The inherent problem in the Amarex/Cytodyn relationship was almost entirely relying on them to do their job...and Not having anybody in oversight...until it was Too late. So,...your assumption that the FDA was addressing Amarex is correct.

Having "the Nader" a Mechanical engineer and Scott as a chairman.. formerly in a totally unrelated field...was flawed at the genious level.
Nader had control issues...Butt,...it had nothing to do with Molecular Science...He would have been better suited to Spacex...another field he had No experience.