The project objectives were as follows: the primary emphasis was on assessing physical capacity, not quality of the capacity, and, where possible, to capture data on prior GMP experience as proxy. The study was to assess the physical capacity, not the quality of the capacity, for manufacturing clinical trial materials for HIV vaccines.
It's my understanding that it was the lack of manufacturing facilities meeting stringent regulatory requirements for vaccine manufacturing that initiated the CHVI program. These vaccines are tested on living people, and we have to ensure the safety of all vaccines. Do you think that study should have included the quality aspects of manufacturing--yes or no?