Published in Lab Business Week, November 11th, 2007
Based on Biovail's discussions with the FDA in an August 14, 2007 meeting, and in accordance with FDA feedback, the submission includes new analyses of the data included in the original New Drug Application (NDA) for BVF-033, but does not include results from any new studies. Biovail anticipates receiving a response from the FDA in the near term. The Company believes the data package is...
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