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)
January 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 January 11, 2010, Neoprobe Corporation (the “Company”) issued a press release announcing that it had submitted an investigational new drug (IND) amendment to the United States Food and Drug Administration (FDA) which includes the design of a proposed Phase 3 clinical trial of the Company’s RIGScan® CR radiopharmaceutical. RIGScan CR is designed to identify and evaluate potentially tumor-associated tissue in patients with colon or rectal cancer. The IND amendment includes a Special Protocol Assessment (SPA) in accordance with the Prescription Drug User Fee Act of 1992 (PDUFA) and current regulatory guidelines, and will be registered on www.clincaltrials.gov following discussions with FDA regarding the SPA. A copy of the complete text of the Company’s January 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 January 11, 2010, entitled “Neoprobe Files Clinical Package for RIGS Technology with FDA.”
 

 

 

 
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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: January 11, 2010
By:
/s/ Brent L. Larson
  
   
Brent L. Larson, Vice President, Finance and Chief Financial Officer
  
       
 
 
 
 

 
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