8-K 1 d8k.htm FORM 8-K Form 8-K

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) October 17, 2007

 


PSIVIDA LIMITED

LOGO

(Exact name of registrant as specified in its charter)

 


 

Western Australia, Commonwealth of Australia   000-51122   Not applicable

(State or other jurisdiction

of incorporation)

  (Commission File Number)  

(IRS Employer

Identification No.)

Level 12 BGC Centre

28 The Esplanade

Perth WA 6000

Australia

400 Pleasant Street

Watertown, MA 02472

U.S.A.

(Address of principal executive offices)

Registrant’s telephone number, including area code (617) 926-5000

 

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

 


Check the appropriate box below if the Form 8-K filing is intended to simultaneous satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨ Soliciting material pursuant to rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨ Pre-commencement communications pursuant to rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨ Pre-commencement communications pursuant to rule 13e04(c) under the Exchange Act (17 CFR 240.13e-4(c))

 



Item 8.01 Other Events

On October 17, 2007, pSivida Limited issued the press release attached hereto as Exhibit 99.1 announcing, among other things, that after the review of safety and efficacy data currently available, an independent Data Safety Monitoring Board (DSMB) has recommended that the pivotal Phase III clinical trial FAME™ (Fluocinolone Acetonide in Diabetic Macular Edema) Study continue under the current protocol, without change. This press release is incorporated by reference into this Form 8-K.

 

Item 9.01 Financial Statements and Exhibits.

 

  (d) Exhibits.

 

EXHIBIT

NUMBER

 

EXHIBIT DESCRIPTION

99.1   Press Release of pSivida Limited dated October 17, 2007

The information contained in this report (including Items 8.01 and 9.01) and the exhibit hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or 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 filing.


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.

 

     PSIVIDA LIMITED
Date: October 17, 2007   By:  

/s/ Michael J. Soja

  Name:   Michael J. Soja
  Title:   Vice President, Finance and Chief Financial Officer


EXHIBIT INDEX

 

EXHIBIT

NUMBER

 

EXHIBIT DESCRIPTION

99.1   Press Release of pSivida Limited dated October 17, 2007