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ADVENTRX Receives Refuse to File Letter from FDA on ANX-530 New Drug Application
Date:3/1/2010

To support a commercially-viable expiration dating period, the stability data provided in the ANX-530 NDA met ICH filing requirements for a new drug.  Site-specific stability data from lots manufactured at the intended commercial manufacturing site also were submitted in the NDA.  

"We believed, following discussions with the FDA at a pre-NDA meeting, the stability data package included in our initial submission supported both NDA acceptance and appropriate expiration dating.  However, we now expect FDA will require additional site-specific stability data to accept our application.  Although we plan to discuss the particular filing requirements with the reviewing chemists, site-specific stability studies are already ongoing and our recent financings provide us the capital to continue this work and, we expect, resubmit the application," said Brian M. Culley, Chief Executive Officer at ADVENTRX.  

"We will work closely with the Agency to understand its new requirements and define the path to a successful resubmission at the earliest possible time," Mr. Culley continued.  

ADVENTRX submitted
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SOURCE ADVENTRX Pharmaceuticals, Inc.
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