All AXDX stakeholders should read the research report issued three days ago by BTIG, an institutional research firm. It's 55 pages and very thorough (and I believe the first formal analyst coverage of the company). What's interesting is that most people are either long-term bulls or bears on the stock (I'm personally in the bearish camp), but this analyst came up squarely in the middle, and issued a neutral rating. While she acknowledges that their system requires a positive blood culture, she points out that it then generates results much faster than anything on the market. She believes that AXDX has a big lead on the competition, and that their product (if cleared by the FDA) will have wide-spread adoption. On the negative side, she thinks the valuation is very stretched, and that success is already priced in - which is why she issued the neutral rating. I highly recommend tracking down the piece and reading it carefully - you will come away with a much better understanding of this company, including both its prospects and risk factors.
Clinical trials underway @ 8 sites. Set to conclude in Nov.. Fast track Maybe? FDA Approval Maybe? This is a machine. It either works or it dont!
It could be the test sites are beginning to get more converts who in effect are insiders and are telling their friends about this new product which actually works as advertised. I have seen nothing from the company about the progress so hopefully it is coming from the sites themselves. Could be wishful thinking!!
I guess I haven't been a stock holder for so long as you, but eve I recall the disingenuous seeking alpha article by an author who considered herself a disinterested party since she was not short the stock. She didn't have an ax to grind: it was the other guy who paid her to publish the article that was short the stock. I don't know the reason for the run up, but if I had my druthers the cause would be a short squeeze.
Is it possible that they have been granted fast-track approval? I thought they had to submit a request, which I would think they would announce. I am having trouble posting to this message board, so if you do too, use DIGM's board. DIGM is a tiny company that virtually never has posts of its own.
I'm a long time shareholder (going back to predecessor institution DDx). I believe in the AXK technology and, with good execution and a little luck, could absolutely see management team achieve the same $7B valuation they received with the last company that they managed (with poor execution and some bad luck, and the stock could be worthless -- a chance I'm more than willing to take). (I won't hold all my stock in wait for my $7B target, but I will hang on to some until that point).
I was expecting a run-up in late August/early September as there are some important dates in September. But I don't think the current run-up is related to the September dates. The trouble is I can't explain the current run-up.
any theories as to why we are approaching 30 now?
Ultimate stock alerts sounds like great information but did not subscribe. This management team have alligned themseves with nothing less than superior professionals. They know where they are and where THEY WILL BE IN 2016. AND STILL GROWING!
You need to check out Ultimate Stock Alerts (google em) because they are killing it right now, Just pulled 34% on their last play in under 2 hours. Check them out today
As a follow up to my original email, I note yesterday's Pima County, AZ press release ( release was about Pima's approval) to the effect that AXDX is taking and expanding additional space is an adjacent building for manufacturing purposes. More space and more employees. This looks like space for manufacturing of the consumables--cassettes, test kits--not a move that a fly-by-night would make IMO. Looks like management believes they are on target, things are moving forward positively and that there will be/is demand for the product and they need to manage quality control. A positive move IMO.
Rapid simultaneous identification and quantitation of Staphylococcus aureus and Pseudomonas aeruginosa directly from bronchoalveolar lavage specimens using automated microscopy
This study demonstrated the ability of the automated microscopy method to simultaneously identify and quantify immobilized live cells of S. aureus and P. aeruginosa extracted directly from remnant BAL specimens. Time from the start of BAL specimen manual preparation to acquisition of the final time-lapse images was less than 4 h. The dynamic range isolate study, however, demonstrated that 90 min of organism growth was sufficient for analysis. The latter finding suggests potential for the method to achieve results within the critical 1–3 h time frame for initiating antimicrobial therapy. In contrast, current quantitation methods require overnight culture for quantitation and separate identification of selected colonies using a biochemical assay or an automated instrument.
Sentiment: Strong Buy
What follows is an excerpt from a test conducted by 2 doctors at the Denver Health Clinic conducted in 2011.
" The Denver investigators split each specimen between standard culturing and Accelr8’s BACcel™ system. Culturing typically requires 3 days to report results. The BACcel™ system reported results in 4 - 6 hours after the lab received a specimen. The study achieved speed in two ways: first, by taking specimens prior to symptom emergence; second, by using the new BACcel™ technology. For this study, bedside clinicians were blinded to the BACcel™ results but received the results of conventional microbiology testing to guide treatment.
Of 35 patients studied with 77 specimens, 9 patients were positive for pneumonia by microbiological criteria from culturing or from the BACcel™ result. One patient tested negative with standard culturing but was diagnostically positive for pneumonia by CDC clinical criteria. The BACcel™ system detected an important pathogen in this patient, near to the quantitative diagnostic threshold. Although the BACcel™ result disagreed with culturing, it agreed with clinical criteria and yielded a correct, early diagnosis that culturing missed.
In this pilot study, overall diagnostic sensitivity was 86% and specificity was 97%, after analyzing for the presence of any of three target organisms and major drug resistance types for each. Targets include Staphyolococcus aureus (“Staph,” including “MRSA”), Pseudomonas aeruginosa, and Acinetobacter species. All of these targets are potentially multi-drug resistant “superbugs,” and are major threats in the ICU. According to the authors, the BACcel™ system delivered results 40 to 66 hours faster than culturing. The BACcel™ system tested multiple target species and multiple drug resistance types at the same time, unlike molecular diagnostic techniques."
Jman. you should have been at the annual meetings and heard Dr's Connie Price and Ivor Douglas from Denver Health rave about the BACcel platform. It's fast and accurate and no, it doesn't need to grow a larger culture. Go visit them in Tucson and see for yourself. I've been there 4 times so far.
Sentiment: Strong Buy
Gainsted, you and I can review the same publicly available information and come to different conclusions. That's what makes markets interesting. The only point I want to clarify is that I'm not interested in convincing anybody to sell their stock (or to short it). I have a long-term opinion and position, and the short-term moves aren't meaningful to me. I'm just trying to add to the conversation.
I sincerely appreciate you taking the time to respond. I have made a first attempt to read the SEC filing and AXDX responses. I agree it is unclear exactly what and how the ID/AST system works. The term positive blood culture as opposed to directly from sample needs clarification. Their marketing material shows a timeline of up to 5 hrs vs 48-52 hours currently observed. I will continue to pursue. Thanks again.
First of all, I'm sorry for what you and your family went through. And as you experienced, the time necessary to grow a positive blood culture is a major problem for patients with serious health challenges (and one that pharmaceutical/medical technology companies with huge R&D budgets haven't been able to crack). I'm not a physician, but I did speak to a board certified Internist, and he was very skeptical that it would be possible to bypass the process of growing a positive blood culture in these cases. But to answer your question, my source is the company itself in a filing they made in September of 2014. Here's an excerpt (the full link can be found by going to www.sec.gov, selecting "company filings", then AXDX, then view the correspondence from 9/9/14):
Inquiry from SEC: "We also note that your system uses a “culture-free process.” Please tell us and in future filings disclose how you achieve cell growth without a culture"
"When we state that the ID/AST System uses a “culture-free process,” we are referring to our system’s ability to directly process a positive blood culture, respiratory, or other specimen without first undergoing a manual culture and isolation process." Then later in the same document, they write: "we plan for the operator to introduce a patient positive blood culture, respiratory, or other sample directly into our system."
Based on that, I'm presuming that their solution potentially accelerates the process AFTER a positive blood culture is attained. This may have value, but falls far short of a solution that could bypass the time necessary to grow a positive culture. It's my personal opinion that the company has been disingenuous by implying (or not disavowing the notion) that they have technology that could bypass the pivotal, time consuming step of generating a positive blood culture.
I don't want to dissuade anyone from owning or buying this stock, since I could be wrong, but I do think these factors are worth pondering
What is your backup for your statement,"Because it now seems clear that they require a culture (despite their past implications that suggest otherwise". The lawsuits are vulture lawyers looking for fresh kill. Perhaps you have proof of your statement. I would be interested in your source. I am an investor because my daughter-in-law was near death for 5 days in the ICU while they awaited the results of a biopsy to determine the cause of a lung situation. In the meantime they gave her an array of antibiotics in the hopes they had the right treatment. The cost from the delay was over $100k and the unnecessary wear and tear was incalculable. My wife experienced the same delay , but was not in an ICU. In my mind there is no question of the need to shorten the time from taking a sample till a proper solution is found. Apparently AXDX has cleared the next milestone on schedule and expects to have 8 trials initiated in the coming quarter. It appears progress is on schedule for FDA approval per todays press release. Look forward to your comments.