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

124

1 await completion of the teratogenicity studies by the
2 two drug companies.
3 CO-CHAIRMAN FAUCI: Diana, can I ask you
4 a question? I think I know what your answer is going
5 to be, but if it isn't, then maybe we could discuss
6 it.
7 That is, given what you've presented as
8 what's ongoing and planned, if we want to make an
9 extrapolation from the picture that we're talking
10 about in adults and say broad, large numbers of
11 children and infants in trial, would you say that
12 based on what we've just heard presented, that we need
13 to go through those studies first before we make any
14 determination regarding a really expanded trial in
15 infants and children? Your answer to that?
16 DR. WARA: My answer is yes. We need to
17 complete the Phase I studies.
18 DR. YUSUF: Could you tell us what the
19 time frame for completion of your current studies are
20 and whether anything could be done so that instead of
21 the traditional time for waiting, can the results be
22 obtained at a much more shortened framework,
NEAL R. GROSS
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