ANX-530 and ANX-514 Timelines
ADVENTRX has entered into an agreement with a new contract manufacturer to conduct process development and scale-up activities for both ANX-530 and ANX- 514. Last week, the Company attended a pre-NDA meeting with the U.S. Food and Drug Administration (FDA) to discuss its NDA submission for ANX-530. The FDA requested additional information regarding the Company's new manufacturer, and as a result, ADVENTRX anticipates the submission of its NDA for ANX-530 will take place in the second quarter of 2009.
ADVENTRX also announced that it anticipates completing patient enrollment in its registrational bioequivalence clinical study of ANX-514 in the first quarter of 2009. The Company expects to announce results from this study in the second quarter of 2009. These changes will not affect the Company's previously announced plans to submit an NDA for ANX-514 in the third quarter of 2009.
On October 14, 2008, a total of nine employees were terminated, consisting of four in research and development, two in clinical, two in selling, general and administrative and one in regulatory/quality assurance. After adjusting to reflect severance costs, these measures will reduce the Company's compensation expenses in 2009 by approximately $1,500,000.
As part of the reorganization, Mark Erwin, previously the Company's
Vice President of Commercialization, was promoted to Senior Vice President,
Operations. In addition, the Company ended its employment relationship with
its Chief Scientific Officer, Vice President, Medical Affai
|SOURCE ADVENTRX Pharmaceuticals, Inc.|
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