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Lifeline Estimates Six Months For FDA Response (PINK:LLBO)

By Mike Brown on 10/26/2009 – 12:54 pm PDT4 Comments

Lifeline Biotech (Public, PINK:LLBO) reported today about the status of their First Warning System™ 510(k) FDA application. The consulting firm, Lifeline Biotech used to submit the FDA application, advised that the “FDA is running anywhere from 30 to 60 days past the normal time expected to provide a response”.

Jim Holmes, Lifeline’s CEO, said ”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.”

The CEO sounded very confident in the progress they have made with the FDA, their testing process, and supporting information they supplied. He also went on to address some concerns regarding their reverse split of the common stock and went on to say;

“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.”

Dealing with these FDA applications has proven to require much patience as we have observed many delays with the FDA in the biotech sector. Lifeline sure has come a long way and we look forward to a response from the FDA.

**UPDATE** 10/26/2009 4:58 PM PDT

More details after contacting Jim Holmes, CEO of Lifeline Biotech, to provide even further clarification of todays news. Jim Holmes has been in contact with their FDA consulting firm who advised the FDA is 30-60 days past the normal time expected to provide a response. The FDA will determine if their technology and testing of over 600 patients would meet the requirements for a 510(k). Jim went further to say that he expects a response on this by the “end of November” but its not guaranteed and its all in the FDA’s hands now. Jim has done everything he possibly can at this point including calling the FDA to get status but the “FDA will not say one word”.

If the FDA responds favorably and determines they would meet the requirements for a 510(k) application then it will take Lifeline and their FDA consulting firm “about one month” to prepare the actual 510(k) application. Once the actual application is submitted then it could take 4-6 months for it to be decided on but again it is all up to the FDA and it could be longer.


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