Alert...LLBO NEWS...Lifeline Biotechnologies Reports on FDA Filing Preparation
businesswire
Companies:
o Lifeline Biotechnologies, Inc.
Related Quotes
Symbol Price Change
Press Release Source: Lifeline Biotechnologies, Inc. On Tuesday February 2, 2010, 1:20 pm
RENO, Nev.--(BUSINESS WIRE)--Lifeline Biotechnologies, Inc. (Pink Sheets: LLBO - News) today reported the regulatory strategy for its First Warning System™ is well underway and the development of an FDA submission for a 510(k) marketing clearance is expected to be filed later this year.
Jim Holmes, Lifeline's CEO, said, "The FDA, in its recent response, opined that the claims concerning the First Warning System’s ability to identify prospective cancerous conditions of the breasts, as set forth in Lifeline’s submission to the FDA in July 2009, would require modification or a premarketing approval process for a Class 3 device. In the development of our regulatory strategy, we have engaged the services of an FDA consulting firm, whose task will be to review the claims made and recommend the appropriate modifications to said claims in order to allow our device to comply with the 510(k) Class 1 or Class 2 medical device guidelines. Our FDA consulting firm is also conducting a thorough review and validation of the testing processes Lifeline utilized in the gathering of physiological patient data obtained from over 600 patients in three different clinical trials. In addition, the FDA consulting firm will make a thorough review of our patent pending interpretative computer software system in order to ensure compliance with FDA verification and validation requirements. Our software system technology was developed by Lifeline Biotechnologies, together with our ‘Pattern Recognition’ experts at Nanyang Technological University, Singapore.
"Once the review has been completed we intend to move forward a fully-compliant 510(k) submission. The submission will be based on the regulatory strategy and could/should be filed by midyear 2010.
"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, and may be increased from time to time for additional required funding or other services, we have no plans for a reverse split at this time."
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.
Contact:
Lifeline Biotechnologies, Inc.
Jim Holmes, 775-324-1933
Jholmes@lbti.com
www.lbti.com
