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

181

1 very important point that we have learned over the
2 last couple of years, the whole issue of looking at
3 Phase II and expanded access together.
4 The DDI expanded access, really, when you
5 go back and you look at "What did we learn? And how
6 important was that in the DDI decision?"; it really
7 was only safety data. I don't think we really learned
8 a lot more in getting some incidence in there.
9 Now, we took it the next step in the
10 expanded access on DDC because we tried to do two
11 different doses. And so we tried to get some more
12 information from there.
13 But looking at the realities of how we can
14 do both the expanded access and the Phase II, I mean,
15 together, certainly trying to get more information out
16 of expanded access, I mean, is something that I still
17 think there's a lot of room to do.
18 MR. DOBSON: I had forgotten a couple of
19 points. That's why I raised my hand a long time ago.
20 But, of course, all kinds of things have happened
21 since then.
22 I think one of the important things that
NEAL R. GROSS
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