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Re: AlpineBV_Miller post# 44562

Sunday, 04/08/2007 3:40:33 AM

Sunday, April 08, 2007 3:40:33 AM

Post# of 257458
>If they were to make approval conditional on successful data from 9902b, that's Subpart H/accelerated approval.<

For biologics, accelerated approval falls under Subpart E, but it’s the same general idea.

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