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| BDSI > SEC Filings for BDSI > Form 8-K on 15-Jun-2009 | All Recent SEC Filings |
15-Jun-2009
Other Events, Financial Statements and Exhibits
On June 15, 2009, BioDelivery Sciences International, Inc. (the "Company") issued a press release to provide an update on the status of its New Drug Application for its lead product candidate, ONSOLIS™. The press release is attached to this Current Report on Form 8-K as Exhibit 99.1.
(d) Exhibits
99.1 Press release, dated June 15, 2009, pertaining to the status of the Company's New Drug Application for its lead product candidate, ONSOLIS™.
This Current Report on Form 8-K and the exhibits hereto and the statements of
representatives and partners of the Company related thereto contain or may
contain, among other things, certain forward-looking statements, within the
meaning of the Private Securities Litigation Reform Act of 1995. Such
forward-looking statements involve significant risks and uncertainties. Such
statements may include, without limitation, statements with respect to the
Company's plans, objectives, projections, expectations and intentions and other
statements identified by words such as "projects", "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 Company's management and are subject to significant risks
and uncertainties, including those detailed in the Company's filings with the
Securities and Exchange Commission. Actual results, including, without
limitation: (i) actual sales results and royalty or milestone payments, if any,
(ii) the application and availability of corporate funds and the Company's need
for future funds, or (iii) the timing for completion, and results of, scheduled
or additional clinical trials and the FDA's or other regulatory review and/or
approval and commercial launch of the Company's formulations and products and
regulatory filings related to the same, may differ significantly 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 Company's control).
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