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

192

1 and how fast to go forward.
2 The first question is: What are the
3 criteria that any product should meet to go forward
4 with efficacy trials, field efficacy trials,
5 irrespective of gp 160 or others?
6 That would be helpful if a discussion
7 could go forward on that. What are the general
8 criteria, safety, immunogenicity, suggestion of
9 efficacy, and what are the criteria within those sets
10 that would allow a product to meet criteria to go
11 forward?
12 The second question is then: Does any
13 particular product meet those criteria once you have
14 established the criteria, and then how many? If you
15 have two or three, that's fine. And then you can do
16 a multi-limb trial. If you only have one or two, then
17 you design your trial accordingly.
18 The third issue is once you have decided
19 which products meet the criteria, then you have to
20 ask: What are the priorities within our program to do
21 this specific trial?
22 Because, as has been pointed out, there
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