[Minutes, Advisory Committee to the Director GP-160 Meeting (1992: Bethesda, Maryland)]

111

1 From a purely puristic standpoint, if you
2 were to look at a product that was shown to be safe in
3 a Phase I trial that had stabilization of a CD4 count,
4 no antiviral effect, and no clinical endpoint as yet.
5 which is agreed what we're dealing with now. -- and I
6 think everyone, including Frank Volvovitz, would agree
7 that that's where we are right now -- that in another
8 time and another age, we would say that that is not
9 sufficient enough data to go ahead to a large
10 multi-thousand patient clinical trial, that you would
11 say then you should go ahead to a Phase II trial to
12 see if you in a controlled fashion could confirm the
13 data that you have now observed in more than one trial
14 in the Phase I trials that have already occurred. In
15 fact, that Phase II trial is already going on. So we
16 expect to get some information.
17 I think that's one separate issue. But
18 since we are dealing with HIV and AIDS, the other
19 issues come up that Mark brought up. I think that
20 this committee, I would submit, should at least
21 discuss this.
22 Given the situation that there is with
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