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Re: TTTav66 post# 131067

Sunday, 11/19/2017 7:12:05 PM

Sunday, November 19, 2017 7:12:05 PM

Post# of 462059

In terms of the disease-specific guidances, was there a reason you picked that route?
Gottlieb: A lot of this comes out of consultations with the centers. So you talk about what their priorities are and then you try to marshal the resources and accelerate what they aim to do. I think that they’re looking at areas where there is no disease guidance and there’s a lot of product development and there’s unanswered questions, and they get a lot of questions. Where is there a significant unmet medical need? So those are the kinds of criteria that they used in adjudicating that. I didn’t pick the 10 areas, the expert groups picked them.

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