8-K 1 v111678_8k.htm
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): April 24, 2008
 
Forticell Bioscience, Inc.
(Exact Name of Registrant as Specified in its Charter)
 
DE
0-27368
11-3068704
(State or other Jurisdiction
of Incorporation)
(Commission File Number)
(I.R.S. Employer
Identification No.)
 
3960 Broadway
New York, NY
10032
(Address of Principal Executive Offices)
(Zip Code)
 
Registrant's telephone number, including area code: (212) 740-6999
 
 
(Former name or former address, if changed from 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:
 
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 April 24, 2008, we received a formal response from the FDA to our application for pre-market approval to sell ORCEL for the treatment of venous leg ulcers. The FDA’s extensive and detailed letter asked for clarification on a variety of safety, efficacy and statistical issues, and questioned the handling of various aspects of the clinical data. FDA also suggested remedies for the deficiencies that they noted. Provided management can remedy the concerns of the FDA, there seems to exist the possibility of a future approval.

Currently, we do not have the funds that we believe are needed to address the comments in the FDA’s letter. We are considering our various alternatives.

 
 
 
 

 
 
SIGNATURE
 
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.
     
 
Forticell Bioscience, Inc.
(Registrant)
 
 		  
 		  
 
Date: April 25, 2008
 By:  
/s/ Alan W. Schoenbart
 
Chief Financial Officer