Navidea Biopharmaceuticals Inc (NAVB)

[TOXX]

My two cents…

As someone intimately familiar with NEOP and lymphoseek, there are issues with the clinical studies submitted to the FDA. Will FDA issue an RTF? I don’t think so. Will FDA approve it for market? No, IMO.

It’s unfortunate because lymphoseek is a superior alternative to anything that’s out there, but the studies were done very poorly and FDAs primary concern is always safety. The current studies demonstrate a significant amount of efficacy, but not enough safety. However in NEOPs defense, I am fairly confident that addition clinical studies addressing those voids of the previous studies are underway.