Published in Food and Drug Law Weekly, July 30th, 2004
The company previously reported that the FDA had issued a clinical hold based upon a preliminary neuropathological finding in an animal safety study.
Since that time, Praecis has been working to resolve the issue by further elucidating the nature of the original finding in several completed and ongoing animal studies, and by modifying its clinical plan.
Praecis has been notified by the FDA that the clinical hold issues have been...
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