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What: Shares of Navidea Biopharmaceuticals (NYSEMKT: NAVB ) , a developer of medical diagnostics and radiopharmaceutical agents, jumped as much as 20% after announcing that the Food and Drug Administration had granted Lymphoseek the fast track designation for sentinel lymph node detection in patients with head and neck cancer.
So what: The fast track designation is a tool the FDA uses that can sometimes speed along the review process for drugs or devices which target a specific unmet medical need. At the moment, there are no lymph node staging devices capable of assisting treatment diagnoses for head and neck cancer, so the designation appears logical. In clinical trials, Lymphoseek correctly identified 38 of 39 patients with pathology-positive lymph nodes, meeting its primary endpoint of a low false-negative rate.
Now what: I've been saying it for a while now, and it bears repeating again: Lymphoseek is an exciting product, and Navidea could be quite the bargain if it gains this supplemental new drug approval for its lead radiopharmaceutical agent. I suspect that the next decade of cancer treatment is going to strongly focus on personalization rather than more potent medications. That means perfecting the diagnostic tools to help patients and doctors determine a best course of treatment. I would certainly suggest adding it to your watchlist.
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