Instead of the eighteen to twenty-four months it formally took a concept sheet to be developed into a protocol, the new system envisions a completed protocol to be ready for FDA submission in approximately four months. Much of the unnecessary bureaucratic hurdles have been removed. Instead of crawling from committee to committee for endless monthly reviews, each protocol team will now consist of specialists from each relevant committee. It certainly sounds more efficient. Theoretically, any member of the team can stop the development process if the protocol is deemed sub-optimal.
Resources are now to be divided among the three RACs.
The scientific agenda will be funded according to what is the best current feasible science. Obviously, the leadership of these three new RACs is of paramount importance. No surprises were expected in electing the chairs and vice-chairs of the RACs. The election for the HIV Disease RAC, however, was a bit of a fiasco. And despite the fact that the HIV Disease RAC forwarded Drs.