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

76

1 MR. VOLVOVITZ: Let me finish.
2 CO-CHAIRMAN FAUCI: Okay. We just --
3 MR. VOLVOVITZ: Larry had 20 minutes. Let
4 me get the questions started.
5 I understand there's an algorithm that has
6 never been validated that was used to determine which
7 MicroGenesys samples would be tested for neutralizing
8 antibodies, while for other products, Well samples
9 were tested. I'd like you to comment on use of this
10 algorithm and whether the algorithm was ever
11 validated.
12 Thirdly, there's been some discussion
13 lately that cellular immune responses may be very
14 important in preexposure settings. I think Dr.
15 Scherer has reported on that. Dr. Valentine has been
16 very interested in observations on cohorts of
17 individuals who are cellular immune-positive and not
18 antibody-positive, implying that their cellular immune
19 response may be very pivotal in the protection against
20 establishment of infection. That being the case,
21 would you show us some quantitative cellular immune
22 response data for the non-gp 160 products?
NEAL R. GROSS
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