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Navidea Biopharmaceuticals, Inc Message Board

  • ukwildcat7 ukwildcat7 Feb 1, 2013 10:52 AM Flag

    SA's Jake King Recent Article

    "Shares of Navidea Biopharmaceuticals (NAVB) are ready to climb as the PDUFA (FDA action) date for the company's lead product, Lymphoseek, is approaching. This is the second PDUFA date for Lymphoseek, as the FDA delayed its initial decision, previously issuing a complete response letter (CRL) due to questions regarding the manufacture of the diagnostic agent. Impressively, the company was able to respond quickly to the FDA and resubmit its application for U.S. approval less than 2 months after FDA's request for information, and the current PDUFA date, when the FDA could grant approval, is set for April 30th. Lymphoseek is a nuclear imaging agent that has significant advantages over currently used products to determine the presence of metastatic cancer in the lymph nodes. Prior to the last PDUFA date, NAVB shares traded up to a high of $4.77, and we anticipate similar activity on the stock in front of the FDA decision in late April. Should Lymphoseek receive FDA's blessing this time around, the shares could trade through their prior high; analyst price targets for NAVB average $6.25. In addition to the potential for FDA approval of Lymphoseek, the company has submitted an application for European approval and could announce a partnership to sell and market Lymphoseek ex-U.S. later this year. Data for Lymphoseek in other cancers are also expected in the next couple of quarters, and catalysts such as these are expected to make 2013 a big year for NAVB and its shareholders."

    Very optimistic and I believe under the circumstances Lymphposeek will be approved much sooner than April 30th!! (JMHO)

    uk

    Sentiment: Strong Buy

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