ANX Timelines for FDA approval.. in second quarter of 2009
Adventrx Pharmaceuticals Inc 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 to discuss its NDA submission for ANX-530. The FDA requested additional information regarding the Companys new manufacturer, and as a result, ADVENTRX Pharmaceuticals, Inc anticipates the submission of its NDA for ANX-530 will take place in the second quarter of 2009
No effect on the Company's previously announced timelines
ADVENTRX's remaining employees will focus their efforts on continuing to evaluate strategic options, as well as continuing the Company's on-going bioequivalence study of ANX-514 (docetaxel emulsion) and activities related to submitting a New Drug Application for ANX-530 (vinorelbine emulsion). The cost-cutting measures announced today should not have a direct and immediate effect on the Company's previously announced timelines.