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

1 Appropriation (Public Law 102-396).
2 As the letter that Dr. Moskowitz sent you
3 already explains, the Department of Defense
4 appropriation mandates that Federal dollars be spent
5 to launch a major efficacy trial in HIV seropositive
6 individuals of a potential AIDS therapeutic vaccine,
7 gp-160.
8 It is important to note that the charge to
9 study this particular vaccine was not paced in statute
10 because gp-160 having been proven to be superior to
11 other candidate vaccines or because of some other
12 compelling scientific or medical imperative. It is
13 the specific role of this panel, all of you gathered
14 here today, to make that crucial determination about
15 the scientific merits of gp-160.
16 In brief, the role of the panel today and
17 in subsequent meetings, if they be necessary, and I
18 suspect they might be, will be to put the brakes on
19 this efficacy trial, as described in the legislation,
20 if, and only if, you decide that the scientific merits
21 of gp-160 are not compelling enough to make it a
22 worthy candidate vaccine for a large scale Phase III
NEAL R. GROSS
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