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Biotech / Medical : VD's Model Portfolio & Discussion Thread
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To: scaram(o)uche who wrote (8629)2/28/2001 8:07:47 AM
From: Elmer  Read Replies (1) of 9719
 
Hi Richard,
HGSI just got Orphan Drug status from the FDA on one of their candidates in Phase I trials, BlyS, for CVID. Does that mean they can start selling it even though it hasn't shown efficacy (I'm perhaps incorrectly assuming Phase I is only safety here). How does this work. Don't they have to show efficacy before sales are permitted?

Thanks again
David
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