UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 8-K

CURRENT REPORT
Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934

 
Date of Report (Date of earliest event reported)
March 11, 2010

 
NEOPROBE CORPORATION
(Exact name of registrant as specified in its charter)

 
Delaware
0-26520
31-1080091
 (State or other jurisdiction
(Commission
(IRS Employer
of incorporation)
File Number)
Identification No.)

 
425 Metro Place North, Suite 300, Columbus, Ohio
43017
(Address of principal executive offices)
(Zip Code)


Registrant's telephone number, including area code
(614) 793-7500


  
(Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
 
o
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
o
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
o
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
o
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
 
 
 
 
Item 8.01.   Other Events.
 
On March 11, 2010, Neoprobe Corporation (the “Company”) issued a press release announcing that it recently met with the United States Food and Drug Administration (the “FDA”) to review the clinical trial results of a Phase 3 investigational new drug, Lymphoseek. The Phase 3 clinical study (NEO3-05) was conducted in subjects diagnosed with either breast cancer or melanoma. The FDA review included the efficacy and safety results of the NEO3-05 study and the Company’s plans for the submission of a New Drug Application (“NDA”) for Lymphoseek. The NDA submission will be based on the clinical results of NEO3-05 and other already completed clinical evaluations of Lymphoseek. FDA encouraged the Company to request a series of pre-NDA meetings in the coming months to review the components of the NDA prior to its formal submission.  The Company indicated to FDA that it plans to submit the NDA following satisfactory completion of these meetings.  A copy of the complete text of the Company’s March 11, 2010, press release is furnished 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
Neoprobe Corporation press release dated March 11, 2010, entitled “Neoprobe Announces Successful Meeting on Lymphoseek Phase 3 Results.”
 
 
 
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SIGNATURES

 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 

 
 Neoprobe Corporation
  
       
       
Date: March 12, 2010
By:
 /s/ Brent L. Larson
  
   
Brent L. Larson, Vice President, Finance and
  Chief Financial Officer
  
       
 
 
 
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