LLBO Lifeline Biotech Inc (CE)

Lifeline Biotechnologies, Inc. (Pink Sheets: LLBO) today reported on the status of the pending FDA submission of its First Warning System™, filed in late July 2009.

Jim Holmes, Lifeline's CEO, said, "This past July we filed with the FDA to determine if our technology and testing of over 600 patients would meet the requirements for a 510(k). We have checked with our FDA consulting firm, the firm that assisted us with the preparation and submission of our July 2009 filing, who advised us that the FDA is running anywhere from 30 to 60 days past the normal time expected to provide a response. We have been advised to exercise patience and we ask that our shareholders do the same. It’s been a long road and we feel we’re getting close. If the FDA is satisfied with our testing process and the supporting information is sufficient, we could proceed and file a 510(k) application immediately. However, the possibility must be considered that the FDA could request additional testing or other technical validations.

"If we can proceed with an 510(k) filing, our best estimate at this time is that it could take four to six months, possibly longer, for the FDA to clear our 510(k) application. Once cleared by the FDA the First Warning System™ could immediately commence commercialization.

"We have had many questions from shareholders and interested parties concerning the status of our FDA filing; we ask that they continue to be patient along with us. As soon as the FDA’s response is received, we will make a press release and post the response on Lifeline’s website.

"We've also received many questions concerning the prospect of a reverse split of the common stock. Even though the outstanding common stock is approximately 2.9 billion shares, we have no plans for a reverse split."

Safe Harbor: This release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 27E of the Securities Act of 1934. Statements contained in this release that are not historical facts may be deemed to be forward-looking statements. Investors are cautioned that forward-looking statements are inherently uncertain. Actual performance and results may differ materially from that projected or suggested herein due to certain risks and uncertainties including, without limitation, the ability to obtain financing, successful development of the Company's product or market acceptance of the product and regulatory and shareholder approval for anticipated actions.

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