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EX-99.01 - PALISADE BIO, INC.v210590_ex99-01.htm
 

 
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): February 9, 2011
 

 
Neuralstem, Inc.
(Exact name of registrant as specified in Charter)

 
Delaware
 
000-1357459
 
52-2007292
 
(State or other jurisdiction of
incorporation or organization)
 
(Commission File No.)
 
(IRS Employee Identification No.)
 
9700 Great Seneca Highway, Rockville, Maryland 20850
(Address of Principal Executive Offices)
 
(301) 366-4841
 (Issuer Telephone number)
 

 
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 7.01    Regulation FD Disclosure

On February 9, 2011, Neuralstem, Inc. (“Company”) announced that the U.S. Food and Drug Administration's Office of Orphan Products Development has granted it orphan drug designation for the treatment of Amyotrophic Lateral Sclerosis (ALS) with its human spinal cord derived neural stem cells (NSI-566RSC), currently in a Phase I safety study to evaluate the safety of the product and the surgical route of administration in a wide range of ALS patients.   A copy of the press release is attached to this report as Exhibit 99.01.

The information contained in this Current Report on Form 8-K and the exhibits attached hereto shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall such information or such exhibits be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing. The information set forth in this form 8-K and its exhibits shall not be deemed an admission as to the materiality of any information within this report.

 
Item 9.01    Financial Statement and Exhibits.
 
Exhibit Number
  
Description
     
99.01
 
Press Release Dated February 9, 2011
     



 
SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this Report on Form 8-K to be signed on its behalf by the undersigned hereunto duly authorized.
 

NEURALSTEM, INC
     
By:
 
/s/ I. Richard Garr                              
   
I. Richard Garr
Chief Executive Officer
 
 
Dated: February 8, 2011