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United States : Navidea Biopharmaceuticals to start test development process for intravenous injection protocols.

Following a recent meeting with the U.S. Food and Drug Administration (FDA), Navidea Biopharmaceuticals has announced that it will start the test development process for its intravenous injection protocols for using Lymphoseek injection in rheumatoid arthritis and other ailments.

CEO Rick Gonzales said,"This collaborative meeting with FDA has enabled us to continue to advance the regulatory process and begin to implement our clinical program in rheumatoid arthritis, an indication that has an addressable market that is substantially larger than the current Lymphoseek indications."

The company said it has already concluded six required non-clinical animal studies for this new route of administration, submitted the summary results in a briefing package to the FDA, and received NIH grants in RA and Kaposis Sarcoma, worth up to $3.8 million to support further development through Phase II studies.

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Publication:Mena Report
Date:Apr 7, 2016
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