2 Min Read
* Says FDA indicated that trial data to support NDA
* Expects Lymphoseek approval in 2011
March 11 (Reuters) - Diagnostics products maker Neoprobe Corp NEOP.OB said U.S. health regulators have indicated that data from a late-stage trial of its radioactive tracing agent would support filing for marketing approval.
The company recently met the U.S. Food and Drug Administration to review the late-stage trial results of its experimental radioactive tracing agent, Lymphoseek, which seeks to determine the spread of cancers in the lymphatic system.
"The results from this meeting have clearly confirmed our pathway for the submission of an NDA (new drug application) approximating our previously disclosed target timeline," said Chief Executive David Bupp.
Neoprobe's Lymphoseek had met the main goal of accurately identifying lymphatic tissue containing cancer, compared with currently used blue dyes, in a late-stage study in March.
The company expects the FDA to approve Lymphoseek in 2011. (Reporting by Anand Basu in Bangalore; Editing by Anthony Kurian)