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| NAVB > SEC Filings for NAVB > Form 8-K on 1-Nov-2012 | All Recent SEC Filings |
1-Nov-2012
Other Events, Financial Statements and Exhibits
On October 31, 2012, Navidea Biopharmaceuticals, Inc. (the "Company") issued a press release announcing that on October 30, 2012, the Company filed the resubmission of its new drug application for LymphoseekŪ to the U.S. Food and Drug Administration in response to the complete response letter received by the Company in September 2012. Lymphoseek (technetium Tc 99m tilmanocept) Injection is a novel, receptor-targeted, small-molecule, investigational radiopharmaceutical used in lymphatic mapping procedures that are performed to help stage cancer. Lymphoseek is designed to identify the lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer.
A copy of the complete text of the Company's October 31, 2012, press release is attached as Exhibit 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 October 31,
2012, entitled "Navidea Biopharmaceuticals Resubmits New Drug
Application for Lymphoseek to FDA"
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