Yesterday, Lifeline Biotech released a press release that details highly important information relevant to shareholders. While some of the information can be confusing at first, a brief overview of how the device approval process works will help to give an understanding of what the real meaning of yesterday’s PR was all about.
First, to understand yesterday’s press release you have to understand the Device Approval process. This article will go step by step through that process and explain where Lifeline ran into some headwinds which has caused it to consult with an FDA consulting firm.
What are the steps?
Alright let’s pull up a schematic of the FDA’s Device approval process (here). This is a broad overview of what steps are needed to bring a new medical device to the market. At first glance this chart might seem much more simple than the usual drug approval process, but imbedded in each step are multiple hurdles that each device manufacturer must meet. So let’s take a look at all of the steps and look how Lifeline has performed in the process. And since Lifeline has stated their desire to get the device approved through the 510(k) process it makes it much easier to see what steps they have to take.
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Good evening,
As I always enjoy reading your posts, this one was right on par with the others. It contained enough information to where I don’t need to ask a bundle of questions, while also leaving enough information to allow anyone to make an educated inference as to whether or not they’d like to invest in this particular company. Well done, mate.
I like what I read here. My DD is limited to what LLBO says their product is and if their product works well, I have no doubts that it may go for class 2 or class 3. Think about it, Class 3 PMA would mean human trials, this is freaking testing device and not treatment so you can pretty much do 1000 tests in single day and then spend the money to do 1000 memograms on same subjects. Once tests are completed, you will get clear picture of hits and misses that will determine the potential of this device. If you remember, GTHP has same percentage of misses in detecting cervical cancer as does the surgrical invasive procedure. What if LLBO also comes out with same outcome? I am talking $$ here.
We need to somehow get to the bottom of LLBO, find out where this device was used for initial trials, what is going on now as far as testing goes, etc. Worst case is that this goes to $0 and we lose all our money. Best case is what make 1000% to 10,000%, risk is fraction of reward here and hence worth speculating.
How can we get in touch with those who have tested this like medical professionals other than relying on what LLBO says? Anyone? emeil at at infofiles@gmail.com
Thanks for your good work on this blog, but I think in this specific case you’re way off the mark. I did some DD on this LLBO company a while back, and posted it on the Google message board. I got a lot of grief from the stock pumpers, but anyway here’s the gist of my post again…
1) The CEO of the company is a guy called Jim Holmes, and they have a Chief Medical Officer, and that’s it! No scientific advisory board, no board of management, no CFO, no other positions. It is a two-man operation only. No manufacturing facility, no PR office, no staff. No job listings in any of the trade publications.
2) The press releases and everything else that would normally be handled by an IR (investor relations) office in a regular company, are all handled by Holmes. The guy even put his own personal e-mail address and phone number at the bottom of the press releases! The CEO and the IR person are the same person. Until a few days ago, Holmes didn’t even have a company e-mail address – he posted his personal AOL address on the company website (it changed last week – use the Internet Wayback archive if you want proof).
3) Their office consists of a suite in an out-of-town office park in Reno NV, shared with marriage counselors, weight loss consultants, and other half-baked businesses. The company was incorporated in 1986, and appears to have not done much since then. You’d think 20+ years would be enough for them to bring a product to market – apparently not. Historically this company has not had any significant revenue stream.
4) Their “product development” page doesn’t actually tell you anything about their product. Why? Because they don’t actually have a product yet. What they filed with the FDA is a request for classification of what their product actually is. Is it a medical device? Who knows. Is it a software package? Possibly, based on what’s out there. It appears they have some weird electrode thing which attaches to the breasts (32 electrodes in total), to detect cancer via changes in temperature. It must be worn over a period of several DAYS, since apparently it is based on circadian rhythm changes in temperature. I can picture it now… “madam, would you rather spend 5 minutes having a mammogram, or walk around for 2 days with 32 electrodes hanging from your norks?”
5) All claims that they are seeking FDA approval, or permission for marketing, are simply nefarious. What they are seeking is CLARIFICATION from the FDA about exactly what they have. Once that is clear, then they can BEGIN to file for some type of regulatory approval. That process is long (years). Do not expect anything at the FDA to happen fast – there are numerous delays currently in place there.
6) The chief Medical Officer is Louis G. Keith, who claims to have published over 500 articles (on the LLBO website), but a quick search of PubMed (the only medical publication database that matters) reveals only 126 papers. Only one of them is about this technology, and appears to describe a trial in Singapore. The lead author (contact) is an ADJUNCT scientist at the National University of Singapore. The journal it is published in (J. Med. Syst.) has an impact factor of 0.67 (i.e. very very obscure). There are no other publications about this technology, what it is, how it works, and any clinical trials. This is not exactly high impact science which would hold credibility in the US biomedical field.
7) They don’t file financials with the SEC. **This was back in September 2009 – they started filing (for the first time in their >20 year history) a short while after that.
9) They have NO patents. Nada. Not a single piece of intellectual property coverage. Their website doesn’t list any, and a search of the USPTO site reveals no patents issued to any of the company officers. The PAIR site (patent application information retrieval) which covers patents in progress, also gives no hits.
10) They have 2.8 billion shares outstanding. Current share price (0.0015) would suggest market cap’ of about $50m, which is insane.
If you want any more proof that LLBO is just a pump and dump operation, just go read the Google message boards on this stock from September and October last year (2009). It even got covered by stockshaven.com… I posted some negative comments on the page, and the webmaster deleted them!
Bottom line, LLBO is a straight P&D pile of a$$, and you should run away very fast.
First, I would like to point out I don’t invest in any stock I write about because it would bias any estimate I give. Second, the post focused on where the company is at in the approval process so I am not sure as to how I am “way off the mark,” as you stated. I stated in the article that the company is going back and forth with the FDA in the classification process of their First Warning Product, which is legitamate and true. The article focuses on the regulatory process moving forward, I did not however, make call as to whether the device would or would not be approved under FDA guidelines or focus on the company’s financial position. Which is why I am a little miffed about the “way off the mark” comment that you posted.
On a side note, I am not sure if are aware that the company technically may not even have to go through the FDA approval process to sell this product. There is another process for devices which side steps FDA guidelines that is called CLIA certification. In one sense this process could possibly allow the company to sell their test without ever achieving a nod from the FDA. Many lab companies have gone this route lately because it is easier, the only problem with going for a CLIA claim is that they cannot make medical claims backed by the FDA.