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Biotech / Medical : VD's Model Portfolio & Discussion Thread

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To: Rocketman who wrote (5548)9/1/1998 12:16:00 PM
From: Kushi Kullar  Read Replies (1) of 9719
 
<<The company noted that one important issue that may delay re-filing beyond October is a potential FDA requirement for another trial to bridge from the manufacturing process used for the Phase 3 pivotal trial to the process planned for commercial production. >>

How significant is this issue?
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