LLBO - Lifeline Biotechs

[zeroveritas]

Lifeline Biotechnologies Reports on FDA Filing Status

Oct 26, 2009 14:35:00 (ET)

RENO, Nev., Oct 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."

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.

SOURCE: Lifeline Biotechnologies, Inc.

Lifeline Biotechnologies, Inc.
Jim Holmes, 775-324-1933
Jholmes@lbti.com



I suggest everyone takes $500, buy 100k+ shares of LLBO and sit on it for a month or 2. You will be happy you did. 10- 20 bagger IMO.

[lordog]

I have about 150000 share of LLBO, Just got news that their product's FDA's 510K might get push back about 6 month, this might be a hit. but once it is approved LLBO should go up alot, let's hope it get through (Fingers Crossed)

[zeroveritas]

I have about 150000 share of LLBO, Just got news that their product's FDA's 510K might get push back about 6 month, this might be a hit. but once it is approved LLBO should go up alot, let's hope it get through (Fingers Crossed)

I have about 600k shares total now, trying to get a million picking up on dips.

you only have to wait about 30 days to sell half your shares for profit if you want, or just stay long up to you. between now and 30 days we will hear back from FDA on the First detection system classification, after we hear back from the FDA on what to classify the product as then immediately following LLBO will submit the 501k for the First Detection breast cancer awareness.

It should go from .02-.10 range following the classification news, another 3-4 months later it could get as high as .25 - .30 and if it is approved then who knows maybe a dollar, it's hard to say.

so no worries hold long and you will be rewarded.

[calhawk01]

LLBO-

All i gotta say is that people are freaking dumb.

So this is what we have here:

From On 8:00 am EDT, Wednesday September 23, 2009,

“There have numerous questions concerning the status of our current FDA filing. To our best belief, our hopeful expectation is for a response around the end of September. However, our FDA advisors and consultants have indicated the FDA is running about 30 days behind schedule.”

On 8:30 am EDT, Monday September 28, 2009

“We have had questions on our current FDA filing. We await the FDA’s response, which could be received as early as the end of September. However, that is probably optimistic and it could be some additional 30 to 45 days before we receive the FDA’s response. As soon as we have the response we expect to release the information to the public.

On 2:35 pm EDT, Monday October 26, 2009

"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.

Ok, so basically, what i derive from all of this is that the "normal" date for them to hear back from FDA for the classification for their device was end of September. However, the they are advised that FDA is running late and that it could be 30-45 days late. 45th day is about November 15th. We are still on schedule. Nothing has changed before or after this press release. Stupid people just do not know how to read. LLBO was ready to explode. The management simply reminded it's shareholders of what they have been saying in the past.

On a different note they 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 above was also common knowledge if you have followed a BIO tech stock. I believe once they recieve the classification for their deivice they will file for the approval to market their product. Now the question i want everyone to answer is this, "How many stocks do you know that are trading below a penny that have filed for marketing approval with FDA?"

I will average down. Wait for November 15th. Hopefully they hear from FDA before that. Once they receive their classification of their device -- they will file with FDA to be approved for marketing. Soon as they do that i think we will be .01+ penny.

This is my analysis of this situation. We are playing with fire. Good luck.
-----
Completely off topic, but check out my thread on HSM:
source: CalHawk01's Under $1 picks - Page 61 - HotStockMarket Message Boards

[erlik]

It looks like all devices related approvals are running late nowadays: NEPH, BIEL and LLBO.

I think that the issue is at the FDA level (maybe related to the fact that the device section leader changed recently) and has little to do with the actual result of the approval.

It is normal that the companies keep their shareholders informed of the situation. This is a welcome change from the silence investors have received from NEPH.

We will have to be a little bit more patient than usual, however I think it is much less of a problem for long term plays like LLBO and BIEL than for a short term ones like NEPH.

[calhawk01]

Mike, you posted the article on LLBO a couple of days ago.

Any new updates on when the CEO is going to update us to make the previous press release more clear?

BTW-

The guy who wrote the article on LLBO on this website messed everything up. I don't appreciate him not even mentioning that LLBO is waiting for the classification for their device which has been 30-45 days from the normal date. The normal date is end of September! And the 45th day is November 15. I don't appreciate how this guy single handidly manipulated the entire LLBO market by saying , "Estimates Six Months For FDA Response" as it's headline. For your information Mike, LLBO hasn't even received the classification for their device yet! Again, i don't appreciate you not even mentioning once about the upcoming, nearby date when LLBO will receive their classification, and then "immediately" file for the 510(k) -- WHICH will take 5-6 months.

How did you single handidly manipulate the LLBO market? Your article is the only article being fetched/posted on LLBO's Google page.

Way to go buddy, i hope you loaded the boat. You are very clever at using "QUOTES" from a press release. *Applauded.

[calhawk01]

Here is the email from the IR guy that i just received. It is regarding the confusion that has been caused by this Mike guy.

LLBO is still on schedule and should hear back from FDA anytime - end of November.

[FavStocks]

calhawk01, why are you confused but the new 30-60 day timeline? The old PR said 30-45 days but don't you think the most recent PR is more accurate than one at least a month ago?

Bottom line, like the article says and like your email screenshot says it is all up to the FDA. LLBO can guess 30-60 days more and we all hope its sooner but its when ever the FDA gets around to it... Dont also forget the actual 510K has not been submitted yet... The application has not even been filled out! It will take about a month for them to prepare the application after they find out the classification from the FDA. So I would say your about 8 months away from an actual approval assuming the correct classification, FDA doesn't need more data, testing, time, etc...

Is that really the PR guy? You know the PR guy (Mr Holmes) is also the CEO right? Why does he have an @aol.com email address??

[calhawk01]

I'm not confused about the date. However, I think you are still confused about the estimated date. Initially it was 30-45 days from end of september to hear back from FDA. Now it is estimated to be 30-60 days from end of september.

What you and your buddy is trying to spin off is that the fda is going to be a another 30-60 days from november 15. Which is incorrect.

I know it is up to the FDA. All dates are estimates. However, FDA has been here for a while and they do finish certain jobs. And yes you can get a average of how long it takes FDA to review such applications. Hence, end of november is a estimate; but on average FDA should be done reviewing the application. History repeats it's self.

Now also they CEO has previously said that they will file the 510(K) immediatly after they receive the classification. Yes, they have also said it will take a month for them to prepare the 510(K). Now assume that LLBO recieves their classification end of november. End of december LLBO files for 510(K). Do you know where LLBO will be trading ?

Finally, go to Electronic OTC Markets - Quotation, Trading Systems, OTCQX, OTC Issuer Services search for LLBO's company information. That is where I got the email address from. So stop trying to spin it off as a fake email.

My last question to you is that, how come there was no mention of the pending classification of LLBO's device on the article you have posted on your website. YOU SAID it yourself, 510(K) hasn't even been filed yet. YET, you allowed a article on your website that said the 510(K) could take 4-6 months to be approved! Don't you think that's a little unethical?

[FavStocks]

I would chill out if I were you. I dont mind talking about the facts with you and even dissecting the news but dont start attacking and fill the forum with junk


First, don't tell me I am discrediting your email or spinning anything. I am saying it is a unprofessional for a public company to have a @aol.com email address (unless you are AOL) in my opinion and I am sure many will agree. But his email address does not change or discredit what he says via email.

Second, why you so hung up on this classification? From my understanding LLBO doesn't know how to classify their product or they dont know if they have enough testing data so they asked the FDA what their product classifies as. This way LLBO doesn't waste time. You think that once LLBO knows what application to fill out this stock will rocket? Why? Application has not been completed or even filled out yet.

Third, yes I do see the article mentions the 30-60 day delayed decision. Also goes on to say "The FDA will determine if their technology and testing of over 600 patients would meet the requirements for a 510(k)" and "If we can proceed with an 510(k) filing" so obviously it talks about the delayed decision and if they can proceed with the filling.

Last, dont say its "unethical" to talk about how long the application will take when it hasent even been filled yet. You should take this up with the CEO Mr. Holmes when he stated in a press release HE WROTE; "could take four to six months, possibly longer"

Lifeline Biotechnologies Reports on FDA Filing Status - Yahoo! Finance

When LLBO finds out what classification their product is in I don't think the stock will move much if at all. Why you ask? Because the CEO will probably say something like we can now work on filling out the application in the coming months and after we submit it the FDA might take about 4-6 months to review it.

Whats is so exciting about LLBO working on filling out an application that might take 1 month to prepare and 6 months to review? It will be exciting IMO closer to when the decision on the actual filled out submitted application is expected many months from now But this is just my opinion and I am not long or short but I hope it is a multi-bagger for you and everyone else. I wouldn't wish any different for anyone else...