- Final manufacturing activities for ANX-530 NDA re-started
SAN DIEGO, June 29 /PRNewswire-FirstCall/ -- ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) today announced its plans for the remainder of 2009.
Following the financing that closed earlier this month, ADVENTRX has re-started the final manufacturing activities related to submitting an NDA for ANX-530. In addition, the Company will continue to evaluate the data from its recently-completed bioequivalence study of ANX-514 and plans to seek a meeting with the FDA to discuss the results. For the near-term, the Company intends to maintain its cost-efficient and flexible infrastructure by engaging consultants on a project basis and outsourcing substantially all of its development activities to specialized vendors and contract development organizations.
"We believe ANX-530 has a clear path to NDA submission that involves a small number of remaining activities and our recent financing allowed us to very quickly re-start much of that work, as well as to continue to evaluate the best path forward for ANX-514. An update on our NDA submission timeline will be provided as critical activities are completed; however, our goal is to submit the NDA around the end of 2009," said Brian M. Culley, Chief Business Officer at ADVENTRX. "The extensive market research and analysis we commissioned from independent third-parties suggests there is an attractive market opportunity in the U.S. for ANX-530, which market can be accessed with a small, cost-effective sales organization."
"Given the limited cost of the remaining development activities leading to an NDA submission, we determined that the value of ANX-530 to our stockholders would be maximized by raising the necessary capital to move forward independently. This decision and our ability to file the NDA r
|SOURCE ADVENTRX Pharmaceuticals, Inc.|
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