MicroGuy
Posted - 1 day ago
$AXDX You are conflating pre-clinical and clinical data collection. Specific had been collecting pre-clinical data at those same sites for a while prior to starting the trial. Axdx’s pre-clinical data boiled down to in-house runs. That is precisely what I am referring to when I am talking about quality, and, as a result, predictive utility of such data.
liability1
Posted - 2 days ago
$AXDX Bought more today !
liability1
Posted - 2 days ago
$AXDX BUY WATCH YOU CAN NOW AND HAVE A MERRY CHRISTMAS !!!!
Esau815
Posted - 2 days ago
$AXDX Specific had 6 Clinical trial sites vis a vis AXDX's 4. Go ahead and extrapolate all you want. he SPECIFIC REVEAL® Rapid AST System was evaluated in clinical trials at 6 hospitals in France and England3. The study mentioned in the press release states: "Clinical evaluation of the SPECIFIC REVEALTM with Gram-negative bacteremia samples in 6 hospitals in France and England – 2021.
MicroGuy
Posted - 3 days ago
$AXDX I completely understand the value of workflow where ID is followed by AST - this is how it works in the clinical microbiology lab. However, they are inherently different businesses. For example, Roche has a great ID business without ever having AST business. Your claim that they ”absolutely need it” is false. If you had bothered to look at the quality (breadth, coverage, number of sites) for Specific pre-trial data, you would easily see that Axdx’s results were inadequate. Hence, my opinion on the projected performance in clinicals. These things are related - same system is employed.
Esau815
Posted - 3 days ago
$AXDX Micro Guy and I have a disagreement about this big time. ID and AST are intertwined. Exhibit A was BM's Specific purchase. Indeed it was THAT purchase that spurred BDX and others to adequately compete as a workflow platform. I also take umbrage that he somehow knows what the AXDX Clinical Data trials are showing. Impossible unless he has access to material non public information. That's under lock and key until they release it. The Pre Clinical trials were more than adequate and they released that a while ago.
MicroGuy
Posted - 4 days ago
$AXDX You make many statements here that are misleading. For example, I am not sure why you are conflating ID and AST markets/players? Reason being is that ID is employed for the world outside of bacterial infections (e.g. viruses), where AST has no relevance. So, you can’t compare these offerings directly. While large companies try to bundle offerings, it does not drive clinical usage/adoption. Labs will purchase what makes sense and what is cheaper. Period. Instead of trying to analyze this industry, I’d pay more attention to: 1) performance data, 2) track record, 3) financials, of the given company.
liability1
Posted - 4 days ago
$AXDX Micro guy go in to AXDX now and stay 3 month just trust me !!!
Esau815
Posted - 4 days ago
$AXDX Newer topic: 1. Warrant exercises. The January, 2024 Blair raise was an abject disaster. (Shockingly, the August, 2024 debt raise was far less onerours.) It seemed as if Blair went out of their way to screw everything up and boy did they. The end result was 6.8MM units which had 1 share of stock and a warrant exercisable at $1.65--all for $1.50. 2. Given their recent 13-G filing, it looks like Armistice took part in the raise--but other than that? Can't really tell. 3. For several months, I thought that share price would never get over the $1.65 strike price--but it's been there for quite some time now. So there are two avenues here and both moderately positive; a. Funds ditched stock and kept warrants. This is mildly positive because the concentrated overhang is likely gone. Likely that some funds lightened up. b. Last Q showed $500K or 166K exercised.
Esau815
Posted - 5 days ago
$AXDX Need a little primer here. There are two types of ID machines. Maldi Tof and Molecular. BioMereiux has about 50% of the Maldi Tof business. Bruker distributed by BDX is about half that. The molecular business is dominated by Roche. Each has advantages and disadvantages. One a lab has a BM machine or a Bruker machine or a Roche machine it is a MAJOR ordeal to change out. Thus highly unlikely that a Roche Cobas customer is going to throw out their entire investment in its tech because "Vitek can do isoaltes for $1" At this point Roche has no AST. Even if Micro Guy is right that Vitek costs only $1 the bottom line is that BM does not have 100% of the ID market and getting rid of what's already been invested in is unlikely to frequently occur
MicroGuy
Posted - 5 days ago
$AXDX There are 3 major automated isolate AST systems on the market (serving 90% of customers): Vitek 2 (BMX) MircoScan Walkaway (Beckman) Phoenix (BD) Vitek 2 enjoys 3x market share compared to either of the other two. Vitek’s testing panel is broad and includes identification as well. Something that is hard to attain (and get approved) by a new entrant. But it’s main advantage is a very low price per test. So, it already dominates automated isolate AST. Will its domination increase? Not sure, but it’s essentially a lab standard today.
Zedemel
Posted - 5 days ago
$AXDX so Vitek2 will take all the market?
Esau815
Posted - 6 days ago
$AXDX No snark here. Take a look at Selux's cap table. We're not talking minor league players here. RA Capital? North Pond? These are really, really smart guys. And they just ponied up $45MM to Selux. Suffice it to say that they would not be doing so if they felt there was no clinical adoption. Especially North Pond who is a new investor and doesn't have to worry about sunk cost. Their cap table is infinitely more reputable than Indaba, Chicago Ventures and just filed Armistice. (What a collection.) (For fun Google 'recidivist" and "Chicago Venrures). Additionally, Biomerieux does not have 100% share--it's closer to about 50%.
MicroGuy
Posted - 6 days ago
$AXDX I share your concerns only on one point throughout this thread (and previous threads), and it is your point #4: * Rapid AST for isolates is useless in terms of these new systems. Reason is, Vitek 2 produces reliable results on isolates in 6-8 hours on average and is ~$1/test card. * Rapid AST for blood is not a game changer in clinical world. At price points that are communicated by all of these companies, there will be very little adoption. Don’t have to look far - AXDX Pheno has shown us all that that is the case over last several years on the market (when it was the only cleared system to do that). Companies hype this up so much to justify high test prices (to recoup their r&d investments). Sorry, clinical labs don’t have extra budgets for a ”nice to have”. Can they deliver same accurate AST results from blood as they do from isolates at that same price point? No, they cannot. Hence, there will be next to no clinical adoption.
Esau815
Posted - 6 days ago
$AXDX Found the weakness of Selux NPG system. It requries THREE separate components--Separator, Inoculator and Analyzer--that likely require a ton of lab space while Wave is an "all in one" system" that takes up a fraction of the lab space. Selux uses something called NPG technology while AXDX Wave uses holographic imaging. Selux has FDA while AXDX is likely a year away. Given lab space is at a premium, Selux might be facing a big hurdle to get so much physical equipment sold Micro Guy? You're on the floor. Refute me if I'm wrong about this.
Esau815
Posted - 6 days ago
$AXDX So to expand upon my previous post. This is what concerns me the most. 1. I'll first start with what concerns me the least--and that is whether or not Wave works. If it doesn't work this is a zero and we're on to the next story. I would find it hard to believe that Phillips would have been able to raise that final $15MM on sketchy data. 2. Ironically, it's the success of Selux that concerns me--and not because of the competitive threat. 3. What concerns me is that they have not partnered with one of the Big Guys. That they're going alone until at least they generate a bunch of revenue. By the way--should note that their estimated market cap is about $250MM though in private hands so it's an estimate. 4. If I know that selling is an uphill climb without a Big Guy name, they must as well. And so the big concern for me for Axdx--is there a complete lack of interest in rapid AST from the Big Guys though it appears that the desperately need it? Unknown
Esau815
Posted - 1 week ago
$AXDX To be honest. What's confusing me at this point is that Selux does indeed have FDA and as of now is not partnered with anyone and is indeed employing a sales force. And....I'll give this to Micro Guy--does this mean that there isn't much interest in rapid AST in general? I was always under the assumption that the Big Guys (Thermo, Roche, BDX, Biorad, BC) wre chomping at the bit to complete their portfolio. I'll assume the guys at Selux aren't dumb. In this day and age do they really believe that doing this alone is their best option? Or is it their only option. When/If AXDX gets Wave approved their turnaround times will be faster--but realistically we're just less than a year away.
Zedemel
Posted - 1 week ago
$AXDX many good opinioni here, but no one goes to the juice. Doing some bets on the story final: 1. Wave good but no buyout, hopefully stock price raising slowly with time 2. Wave good and bought , final stock price? 3. Wave no good, bankruptcy, stock to zero.
Esau815
Posted - 1 week ago
$AXDX And my reply to MicroGuy: 1. It appears that Selux is "going it alone" on the sales model. Good luck to them. In this day and age it's Oprah "size matters". AXDX is commited to getting a partnership agreement. 2. We agree and disagree regarding Wave efficacy. I believe that Philips would never have let this go to clinical trials if his preclincial trials were weak--indeed he published the numbers in the Q2 call. You believe that Wave is a paperweight. We do agree that if Wave is worthless that it's curtains for the company. 3. There are a good number of potential buyers/partners for AXDX. Roche, BDX, BIO, Thermal Fisher, Becton Coulman--there are more. The AST space is expanding so quickly that I find it likely that one of these guys bite. 4. Vitek has 50% market share. Not 100%. If you have a Bruker machine you're unlikely to switch to BM.
MicroGuy
Posted - 1 week ago
$AXDX Again, for the benefit of the community: 1. I've mentioned Selux several times here. Q-Linea, in fact, has had an agreement with Thermo but was dropped by them. My guess is a combination of performance and price per test (Vitek 2 is a stiff competition at ~$1/test for isolates). 2. No need to take my work for it. Just look at FDA's website - they post performance data for all cleared devices. 3. Delay in not the issue (it is, of course, when you're running out of money). The issue is the mismanagement of investor expectations. It is usually mitigated by solid pre-clinical data. Not the case here. 4. Not sure why Arc is even part of this discussion.
Esau815
Posted - 1 week ago
$AXDX Response to Micro Guy 1. Indeed Selux is approved for isolates and PBC--a fact I just recently learned. Curious that they have not secured a distribution deal with Roche, BDX, Thermo Fisher, Bio Rad or Becman Coulter--it would seem to me that all of them have a crying need for Rapid AST. As you might notice by the plethora of names--there are a number of potential buyers. By the way, Q Linea is also in this space--but they're behind AXDX. 2. You know more than I do about specific infections-ABX. I'll take your word for it. 3. Last CC AXDX said that a 510k filing would occur before March 31. A bit of a delay to be sure. As I have said--if you're right and I'm wrong regarding AXDX efficacy then it's game set and match. 4. Think we both agree that it's all about Wave. Arc is a "nice thing" but it won't support ample corporate valuation.
MicroGuy
Posted - 1 week ago
$AXDX BioMerieux already dominates this market with Vitek 2. Remember, market is the isolates, not blood cultures. It doesn't matter all that much who's blood solution will dominate - it is <5% of all samples. And, yes, BMX, has a solution they're rolling out.
liability1
Posted - 1 week ago
$AXDX I think BioMerieux with their system will dominate the market !!!!
MicroGuy
Posted - 1 week ago
$AXDX To benefit this community, here is a response to a previous post by Esau (well, to the non-rhetorical/emotional questions only): $AXDX Challenge to Micro Guy and ZZ: 1. Identify ONE potential competitor who can do rapid AST for isolates. SeluxDx. Competitor actively selling - cleared for both positive blood culture and isolates. 2. Identify ONE infection-antibiotic combination that AXDX is in clinical trials on that you think will not yield a favorable result. Any Gram-negative bacteria that is beta-lactamase producing with, say, peptazol (piperacillin and tazobactam combo). 3. Identify what sources you might have that indicate that Phillips rushed Wave into Clinical trials and that the end result will not be positive. Public information - absence of meaningful pre-clinical data. To publicize that dataset as being "strong pre-clinical" was out of desperation to show "progress".
liability1
Posted - 2 weeks ago
$AXDX Down to $ 1.50 until real news !
Esau815
Posted - 2 weeks ago
$AXDX My POV: 1. Not great. Not horrific. 2. Clinical trials ongoing. Hoping that they were completed. 510 k "sometime in Q1" was bad news in that they previously promised 2024 Q4. With their cash constraints they don't have a ton of wiggle room. Nine months from then? You're talking 2025 year end and the $ is going to be an issue. 3. Possibly the worst analyst I've ever heard in any call. Brackman's junior junior junior analyst reading from a script. Asking about Arc? Pheno transition???? Meaningless. The only relevant question, "Assuming that Wave passes its clinical trials when will distribution/M&A negotiations begin? At the FDA application stage? Or the approval stage? That's the whole ball of wax and that analyst was an embarrassment. 4. Last thought. I blocked a guy who follows me because he said something vulgar about a prominent woman. Anyone who does the same will not be tolerated by me. Get your information from someone else.
liability1
Posted - 2 weeks ago
$AXDX Sold before CC to risky !
Esau815
Posted - 2 weeks ago
$AXDX Binary CC is Thursday. Lots of big volume bids. As if somebody might know something. Rest assured that I do not.
GiantEggHead
Posted - 2 weeks ago
$AXDX Time to ride "WAVE" !