Search the web
Welcome, Guest
[Sign Out, My Account]
EDGAR_Online

Quotes & Info
Enter Symbol(s):
e.g. YHOO, ^DJI
Symbol Lookup | Financial Search
NAVB > SEC Filings for NAVB > Form 8-K on 1-Nov-2012All Recent SEC Filings

Show all filings for NAVIDEA BIOPHARMACEUTICALS, INC.

Form 8-K for NAVIDEA BIOPHARMACEUTICALS, INC.


1-Nov-2012

Other Events, Financial Statements and Exhibits


Item 8.01. Other Events.

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.



Item 9.01 Financial Statements and Exhibits.

(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"

  Add NAVB to Portfolio     Set Alert         Email to a Friend  
Get SEC Filings for Another Symbol: Symbol Lookup
Quotes & Info for NAVB - All Recent SEC Filings
Copyright © 2014 Yahoo! Inc. All rights reserved. Privacy Policy - Terms of Service
SEC Filing data and information provided by EDGAR Online, Inc. (1-800-416-6651). All information provided "as is" for informational purposes only, not intended for trading purposes or advice. Neither Yahoo! nor any of independent providers is liable for any informational errors, incompleteness, or delays, or for any actions taken in reliance on information contained herein. By accessing the Yahoo! site, you agree not to redistribute the information found therein.