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Replies to #44562 on Biotech Values
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DewDiligence

04/08/07 3:40 AM

#44563 RE: AlpineBV_Miller #44562

>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.