qualche news :
http://www.bio-medicine.org/medicin...lts-From-ANX-514-Bioequivalence-Study-4330-4/
ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) today 16 settembre announced that it intends to submit an NDA for ANX-530 (vinorelbine emulsion) by the end of 2009. The Company successfully completed the final manufacturing activities required for the NDA submission, which activities were re-started following the Company’s June 2009 equity financing.
“Our recently completed manufacturing activities represented the last major hurdle before our NDA submission,” said Brian M. Culley, Principal Executive Officer at ADVENTRX. “While we continue to evaluate the bioequivalence and preclinical data, we have begun the substantial process of compiling the information required for a submission, which we expect to take place by the end of this year.”
About ANX-530 (vinorelbine emulsion)
ANX-530 is a novel emulsion formulation of the chemotherapy drug vinorelbine. Navelbine, a branded formulation of vinorelbine, is approved in the U.S. to treat advanced non-small cell lung cancer as a single agent or in combination with cisplatin