On September 10, 2012, Navidea Biopharmaceuticals, Inc. issued a press release announcing that it received a Complete Response Letter ("CRL") from the U.S. Food and Drug Administration ("FDA") regarding its New Drug Application ("NDA") for LymphoseekŪ (technetium Tc 99m tilmanocept) Injection. In the CRL, the FDA noted the decision was focused on issues with third-party Lymphoseek contract manufacturing, and was not related to any efficacy or safety data filed within the Lymphoseek NDA.

A copy of the complete text of the Company's September 10, 2012, press releases is attached as Exhibits 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

Statements contained or incorporated by reference in this Current Report on Form 8-K which relate to other than strictly historical facts, such as statements about the Company's plans and strategies, expectations for future financial performance, new and existing products and technologies, anticipated clinical and regulatory pathways and markets for the Company's products, are forward-looking statements. The words "believe," "expect," "anticipate," "estimate," "project," and similar expressions identify forward-looking statements that speak only as of the date hereof. Investors are cautioned that such statements involve risks and uncertainties that could cause actual results to differ materially from historical or anticipated results due to many factors including, but not limited to, the Company's continuing operating losses, uncertainty of market acceptance of its products, reliance on third party manufacturers, accumulated deficit, future capital needs, uncertainty of capital funding, dependence on limited product line and distribution channels, competition, limited marketing and manufacturing experience, risks of development of new products, regulatory risks and other risks detailed in the Company's most recent Annual Report on Form 10-K and other Securities and Exchange Commission filings. The Company undertakes no obligation to publicly update or revise any forward-looking statements.

(d) Exhibits.

Exhibit
Number   Exhibit Description

99.1     Navidea Biopharmaceuticals, Inc. press release, dated September 10,
         2012, entitled "Navidea Biopharmaceuticals Receives Complete Response
         Letter From FDA for LymphoseekŪ NDA due to Manufacturing Deficiencies."