8-K 1 h40841ae8vk.htm FORM 8-K - CURRENT REPORT e8vk
 

 
 
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) : November 2, 2006
Encysive Pharmaceuticals Inc.
 
(Exact name of registrant as specified in its charter)
         
Delaware   0-20117   13-3532643
     
 
         
(State or other jurisdiction
of incorporation)
  (Commission
File Number)
  (IRS Employer
Identification No.)
     
4848 Loop Central Drive, Suite 700, Houston, Texas
(Address of principal executive offices)
  77081
(Zip Code)
Registrant’s telephone number, including area code: 713-796-8822
Not Applicable
     
 
(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.
Encysive Pharmaceuticals Inc. (the “Company”) announced today that following discussions today with the U.S. Food and Drug Administration (FDA), the Company has submitted a complete response to the July 24, 2006 approvable letter issued by the FDA regarding the Company’s New Drug Application (NDA) for Thelin (sitaxsentan sodium) 100 mg tablets. The FDA is currently evaluating Thelin as a potential new oral treatment for pulmonary arterial hypertension.
The Company expects to hear within approximately 30 days whether the FDA accepts the submission and if so, the FDA will establish a new PDUFA action date.
This Current Report contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements are subject to certain risks, trends and uncertainties that could cause actual results to differ materially from those projected. Among those risks, trends and uncertainties are decisions by the U.S. Food and Drug Administration regarding whether and when to approve our drug application for Thelin™ (sitaxsentan sodium), as well as more specific risks, trends and uncertainties facing Encysive such as those set forth in its reports on Forms 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Given these risks, trends and uncertainties, any or all of these forward looking statements may prove to be incorrect. Therefore you should not rely on any such forward looking statements. Furthermore, Encysive undertakes no duty to update or revise these forward-looking statements. The Private Securities Litigation Reform Act of 1995 permits this discussion.
 
 
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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.
         
  ENCYSIVE PHARMACEUTICALS INC.
(Registrant)
 
 
     
     
     
 
Date: November 2, 2006
         
     
  /s/ Paul S. Manierre    
  Paul S. Manierre   
  Vice President and General Counsel