LLBO
Lifeline Biotechnologies Reports on FDA Filing Status
2:35p ET October 26, 2009 (Business Wire)
Lifeline Biotechnologies, Inc. (Pink Sheets: LLBO) today reported on the status of the pending FDA submission of its First Warning System(TM), 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(TM) 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."
