BioDelivery Sciences Files Annual Report on 10-K and Complies with Nasdaq Marketplace Rule 4350(b)(1)(B).RALEIGH, N.C. -- BioDelivery Sciences International, Inc. (Nasdaq:BDSI BDSI Brooks Divinity School, Inc (Denver, CO) ) has filed its Annual Report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for the fiscal year ended December 31, 2008 with the U.S. Securities and Exchange Commission (SEC). Such Form 10-K is available on the SEC's website at www.sec.gov. In addition, and in compliance with Nasdaq Marketplace Rule 4350(b)(1)(B), the company disclosed that such Form 10-K contains a going concern qualification from its independent registered public accounting firm, Cherry, Bekaert & Holland, L.L.P. Nasdaq Rule 4350(b)(1)(B) requires separate disclosure of a recent audit opinion that contains a going concern qualification. This announcement does not represent any change or amendment to BDSI's 2008 audited financial statements or to its 2008 Annual Report on Form 10-K. Dr. Mark Sirgo, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of BDSI, stated "Similar to last year, the going concern opinion was expected given we are a pre-revenue company. That said, should we obtain FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. approval as expected in the first half of this year for our lead product candidate ONSOLIS(TM), we will receive a significant milestone payment from our commercial partner and should begin to receive royalties on sales this year. We believe these milestones, combined with the continuing development of our company into a commercial enterprise and the opportunities we believe this will present, should help us to address the going concern issue." As previously disclosed, in December 2008, the U.S. Food and Drug Administration (FDA) accepted the resubmission of BDSI's New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) for its lead product candidate ONSOLIS. BDSI expects a decision from FDA on the revised NDA for ONSOLIS in the first half of 2009. BDSI expects to receive milestone payments from its commercial partner Meda AB in connection with FDA approval and commercial launch of ONSOLIS, as well as a double-digit royalty on net sales Net Sales The amount a seller receives from the buyer after costs associated with the sale are deducted. Notes: This amount is calculated by subtracting the following items from gross sales: merchandise returned for credit, allowances for damaged or missing goods, freight of the product. About BioDelivery Sciences International BioDelivery Sciences International, Inc. (NASDAQ:BDSI) is a specialty pharmaceutical company that is focused on developing innovative products to address growing market opportunities, including conditions such as pain. The company utilizes its owned and licensed patented drug delivery technologies to develop, partner, and commercialize new products using proven therapeutics. BDSI's pain franchise currently consists of two products in development utilizing the Company's patented BEMA([TM]) buccal buc·cal adj. 1. Of, relating to, adjacent to, or in the direction of the cheek. 2. Of or relating to the mouth cavity. buccal soluble film technology: ONSOLIS (fentanyl fentanyl /fen·ta·nyl/ (fen´tah-nil) an opioid analgesic; the citrate salt is used as an adjunct to anesthesia, in the induction and maintenance of anesthesia, in combination with droperidol (or similar agent) as a neuroleptanalgesic, and buccal soluble film) a potential treatment for "breakthrough" pain in opioid opioid /opi·oid/ (o´pe-oid) 1. any synthetic narcotic that has opiate-like activities but is not derived from opium. 2. any of a group of naturally occurring peptides, e.g. tolerant patients with cancer, and BEMA Buprenorphine, a second analgesic analgesic (ăn'əljē`zĭk), any of a diverse group of drugs used to relieve pain. Analgesic drugs include the nonsteroidal anti-inflammatory drugs (NSAIDs) such as the salicylates, narcotic drugs such as morphine, and synthetic drugs with at least one potential target indication for the treatment of moderate to severe pain. The company is working with its BEMA technology and its patented Bioral([R]) cochleate coch·le·ate also coch·le·at·ed adj. Shaped like a snail shell; spirally twisted. [Latin cochle technology on products targeted at conditions common to oncology and surgical patients such as pain and infections. The company headquarters is located in Raleigh, North Carolina For other uses of this name, see Raleigh. Raleigh (IPA: /ˈrɑli/, ral-ee) is the capital of the State of North Carolina and the county seat of Wake County. , and its principal laboratory is located in Newark, New Jersey. For more information please visit www.biodeliverysciences.com. Cautionary Note on Forward-Looking Statements Except for the historical information contained herein, this press release and the statements of representatives and partners of BioDelivery Sciences International, Inc. (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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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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