SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or Section 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported) January 14, 2008 (January 10, 2008)
BioDelivery Sciences International, Inc.
(Exact name of registrant as specified in its charter)
(State or other jurisdiction
|(Commission File Number)|| |
2501 Aerial Center Parkway, Suite 205
Morrisville, North Carolina
|(Address of principal executive offices)||(Zip Code)|
Registrants telephone number, including area code: (919) 653-5160
(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 to the registrant under any of the following provisions:
|¨||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 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))|
|Items 7.01 and 8.01. Regulation||FD Disclosure and Other Information.|
On January 10, 2008, BioDelivery Sciences International, Inc. (the Company) issued a press release relating to the U.S. Food and Drug Administrations (FDA) acceptance for filing of the Companys new drug application (NDA) for BEMA Fentanyl, which NDA was submitted to FDA by the Company on October 31, 2007. The press release is attached to this Current Report on Form 8-K as Exhibit 99.1.
On January 14, 2008, the Company issued a press release relating to the expansion of the Companys clinical development program for its lead product, BEMATM Fentanyl, to assess the efficacy and safety of the product for the treatment of breakthrough pain associated with other chronic pain conditions beyond cancer. The press release is attached to this Current Report on Form 8-K as Exhibit 99.2.
|Item 9.01.||Financial Statements and Exhibits.|
|Press release, dated January 10, 2008, regarding the FDAs acceptance for filing of the Companys NDA for BEMA Fentanyl.|
|Press release, dated January 14, 2008, regarding the Companys expansion of its clinical development program for BEMA Fentanyl.|
This Current Report on Form 8-K and the exhibits hereto may contain, among other things, certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements with respect to the Companys plans, objectives, expectations and intentions and other statements identified by words such as may, could, would, should, believes, expects, anticipates, estimates, intends, plans or similar expressions. These statements are based upon the current beliefs and expectations of the Companys management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Companys control).
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|January 14, 2008||BIODELIVERY SCIENCES INTERNATIONAL, INC.|
|Name:||James A. McNulty|
|Title:||Secretary, Treasurer and Chief Financial Officer|