Lifeline Estimates Six Months For FDA Response (PINK:LLBO)
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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**** i wont be rich by x-mas , talk about reverse pr….
I think you are misinterpreting the PR. I’m still assuming, based on this PR that we will have an answer from the FDA by November 15th.
[...] week or so but any of these prices will prove to be a steal if LLBO actually does file. They are waiting on a FDA classification, which is estimated to be announced by the end of November. The First Warning System will most [...]
I have 3062 shares of preferred stock. How do I convert it back to common shares and how many shares of common will it be. Also what will it cost.
Rich,
The series B stocks are worth 10 common stocks. You would need to have your broker/firm get the certs from the transfer agent and they would have to be signed and returned. This whole process takes approx 1 month. With over 2.9 billion shares out there, I would wait until after the Classification announcement from the FDA, then wait until they 510k paper work is filed and LLBO does a R/S or share buy back program. Holmes will be offering another Series B stock Offering after the Classification announcement and 510k filing.
If you converted right now that would give you 30620 shares, if it goes up to 0.03 that would be approx 918.00 less all the cost involved with doing all the paperwork ans commissions. If you hold onto those Series B and wait until there are fewer shares and this goes up after thje 510k Approval, you stand to make a nice little profit. I am in the same boat as you, however I have a few more shares than you. I have asked my broker to get the Certs to have them ON FILE so when the 510k comes back approved I can cut the time in Half that it would take to do this.
I hope this helps.
MM
i AM 69 YEARS OF AGE AND WITH THAT, IT GIVES ME TREMENDOUS KNOWLEDGE IN THE WORLD OF GOLF….EXPERIENCE THAT ALLOWED 12 ACES FROM 1963…I feel like getting a hole in one in the Market place but the difficulty is quite burdensome. Especially with the ups and downs and the this and that……..I chose LLBO to go with and just see what happens….did I do good in your opinion?….I am retired and I feel like doing purchases of Pinks. What the heck, better than TV….but not GOLF.