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Article: Lifeline Biotechnologies Reports on FDA Filing Status.
- Article from:
- Medical Letter on the CDC & FDA
- Article date:
- November 15, 2009
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Lifeline Biotechnologies, Inc. (Pink Sheets: LLBO) reported on the status of the pending FDA submission of its First Warning System™, filed in late July 2009 (see also Lifeline Biotechnologies, Inc.).
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 ...