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Another Crashing Noise From the Basement

In case you’ve missed, it, Theranos (the blood-testing company whose secretive technology has been taking some major blows over the last few months) has reached yet another unwelcome stage in its troubles. First you have people expressing doubts about the company’s product, then you have worries about their customers defecting, then you have regulatory problems (with the FDA breathing down your neck).

All of this is very bad. But now things have reached what may be the worst stage: the company is the subject of a criminal investigation about whether it misled investors. I’ll bet some of them certainly feel misled by this point, but the question is whether they did that to themselves, or whether the company helped them along a bit. Here, see how appealing this sounds:

People familiar with the matter said the subpoenas seek broad information about how Theranos described its technologies and the progress it was making developing those technologies.

Investigators are also examining whether Theranos misled government officials, which can be a crime under federal law, some of the people said. . .

Right. The SEC is also investigating the company’s statements while seeking funding, and no one can be happy about that, either. “We welcome the investigation” is not a phrase that any CEO wants to be practicing – if you go much further along that path, your next lines to memorize are going to start off with “On the advice of counsel, I must respectfully decline to answer on the grounds. . .”

A few questions: where exactly was the company’s illustrious and high-powered board of directors while all this was going on? What are the chances that Theranos can recover from this collapse? And how long will it be before investors line up again to throw sackfuls of money at a 19-year-old with a big biomedical idea? (This guy doesn’t count, and anyway, he’s not doing anything medical, insofar as you can figure out what’s going on at all). My guess is that one of the many ways in which medicine and drug discovery are not like Silicon Valley businesses is that there are few (if any) wunderkinder able to turn the world upside down. If you’d like to believe that there are, you run the risk of investing in the next Theranos, so be warned.

68 comments on “Another Crashing Noise From the Basement”

  1. Hap says:

    I guess their success was more limited than I thought.

  2. oldnuke says:

    There’s a sucker born every minute.

  3. Anonymous Researcher snaw says:

    A friend asks “When will someone dub Elizabeth Holmes Bio-Madoff?”

    With this comment I hereby so dub her!

  4. Bryan L Roth says:

    There is a nice paper in JCI on a head-to-head comparison of Theranos’ with ‘conventional’ approaches https://www.jci.org/articles/view/86318

    “RESULTS. Theranos flagged tests outside their normal range 1.6× more often than other testing services (P < 0.0001). Of the 22 lab measurements evaluated, 15 (68%) showed significant interservice variability (P < 0.002). We found nonequivalent lipid panel test results between Theranos and other clinical services. "

  5. Rule (of 5) Breaker says:

    Apparently Holmes said she feels “devastated” by the developments. I think she means her ego feels that way. In fact, I didn’t recognize her at first since she wasn’t wearing her black turtleneck of arrogance. This should not come as a surprise to anyone aware of the fact that they refused to submit any part of their work to a peer reviewed journal. Overall though, my favorite part is that she famously claimed she had no back-up plan, since having a back-up plan indicates you don’t believe in your original idea. Right, because science and medicine is 100% predictable and all factors are always under your control. She has no business being in the medical industry. She appears to have wanted fame and money and had little interest in the patient. Well, she got what she was after. Now she will be famous as a case study in hubris.

  6. Dr. Manhattan says:

    If you check out the Theranos web site under leadership, among them it lists the following people:
    Riley P. Bechtel is Chairman of the Board and a Director of Bechtel Group, Inc.
    Henry A. Kissinger
    Richard Kovacevich former Chief Executive Officer of Wells Fargo & Company
    James N. Mattis retired United States Marine Corps general
    Samuel Nunn a former United States Senator from Georgia
    Gary Roughead a retired United States Navy admiral
    George P. Shultz Former cabinet member

    Not a single chemist, biochemist, or biologist listed anywhere among the leadership. Just lots of former government to industrial leaders. I wonder how many of them could pass an AP chemistry or biology exam…

    1. Crocodile Chuck says:

      They’re more likely to order up a drone strike on short sellers!

  7. SomeGuy says:

    I like “black turtleneck of arrogance” – sounds very D&D. Too bad it doesn’t protect from the SEC Subpoena of Truth.

    1. Toitlesallthewaydown says:

      All these black turtleneckers (Jobs, Holmes etc) remind me of Dieter and the Shprockets skit by Mike Myers on SNL!

  8. Am I Lloyd says:

    Unfortunately Holmes brought it upon herself with all the secrecy, myth-making and deflections, and I hope Theranos can gets its act together. But I sense more than a hint of vindictive reprisals in the response against Holmes herself. When was the last time anyone in a drug company was “banned” for off-label marketing or for squelching problematic clinical data? When was the last time these standards were applied to a financial company CEO? I find it hard to believe that sexism and pure glee at making a young white female billionaire suffer have not played any role whatever in the the whole Theranos fiasco.

    1. MTK says:

      She made her own bed, but there’s more than a bit of sexism behind the schadenfreude also.

      A large part of Theranos’ appeal was her and she never really seemed to mind that. Throw in the whole black turtleneck thing and it was all just too easy to resent, so now you have the predictable backlash.

      1. Hap says:

        Giving license to sexism (by using it for your ends) is probably a mistake; though it’s not her job to combat sexism, it makes it sort of hypocritical to complain about it when it works against her ends. Don’t call up what you can’t send back down.

        Stories are useful things, but when they have real consequences (money or lives), you need to look at the facts on which the story is built and not just the narrative. When you aren’t able to do that, bad things happen, and when you aren’t allowed to look at the facts behind the story, then you should consider that fair warning. I imagine people’s anger at themselves doesn’t help.

        1. bad wolf says:

          It is beginning to sound like “Give Felisa a Job” 2.0 a bit. A big story given a big push, an ambitious young scientist who ultimately overreaches and shoots themselves in the foot. And while it may seem sexist that both are women, I would say we can just give Ethan Perlstein time.

          (Looks like FWS has been employed finally. Good for her.)

          1. Rhenium says:

            Oh? Where is FWS at? Google doesn’t appear to turn her current position up past LBL.

          2. bad wolf says:

            Her website lists her as a VAP at Mills, a historically women’s SLA college in the Bay Area.

      2. Am I Lloyd says:

        Yes, but people need to go after the company and her negligence, not the turtleneck and her age and chutzpah which after all are all too common among uppity Silicon Valley entrepreneurs. Something tells me that if Holmes were a man then people would be criticizing the turtleneck and the age much less.

      3. Peter says:

        Maybe she should have spent the time to finish Stanford. Though there are some people who go on to great success after dropping out of prestigious universities, there are many more who do not. Apparently, Holmes had herself convinced that she was one of the select few.

        Good looks, youthful optimism, money and influence will only get you so far. At some point, the rubber has to hit the road. Or, as Feynman said, “For a successful technology, reality must take precedence over public relations, for nature cannot be fooled.”

    2. loupgarous says:

      Schadenfreude is an equal opportunity affliction in this case. Elizabeth Holmes managed to attract a Board of Directors (and one assumes investors) full of face cards – Henry Kissinger, the currently reigning Bechtel, Sam Nunn and George Schultz, for example. It’s hard to argue she was this down-from-under scrapper with nothing but drive and education goring for her.

      I read the Journal of Clinical Investigation paper (a 60 patient study, so let’s see a bigger cohort before we call the newsies) and found what I expected to find – high sample rejection rates on Theranos’ finger-stick samples compared to venipuncture-collected tubes full of blood. Intuitively, you’d expect to get better results the more you stuck (no pun intended) with counting molecules, not cells, in finger-stick samples.

      Sooooo… let’s see if SEC can find anything wrong with her “forward-looking statements” before we fit Ms. Holmes for an orange jumpsuit, but Theranos just doesn’t seem to me to be a heads-up substitute for professionally collected and analyzed blood samples. Ms. Holmes could have changed my mind, and that of her other critics, by publishing data in peer-reviewed papers. That’s not a sexist assessment, but goes straight to her due diligence in entering the clinical laboratory business and making representations as to the validity of her process’s results.

  9. Therafraud is a great example of what happens when people outsource their thinking and due diligence. I am sure many investors put in money based on the assumption that someone else who invested (Tim Draper, etc) “did the work”, when in fact nobody did any work at all.

    And many investors and certainly most in the media WANTED to believe the story. Far from there being a “war on women” or any other such grievance industry bullpoop, people so wanted to have a young successful female entrepreneur that they turned a blind eye to the problems, and aided and abetted a con BECAUSE Elizabeth Holmes fit the image of what they wanted to believe exists.

    1. fajensen says:

      *Some* Investors put in seed money publicly to get the hype going while at the same time building up the opposite position – their *real* investment, in Failure – behind the scene!

      It is still fairly easy to get some of the Too-Big-To-Fail-banks to write Credit Default Swaps on the debt of a well-funded, popular (some may even say … hyped), backed by known to be hard-nosed financiers, company. If the company go bankrupt, it defaults, the CDS pay out and then someone, who had the foresight to buy those CDS, can afford another island.

      … The whole thing works exactly like buying a fire insurance on your neighbors house.

    2. tangent says:

      Do you know what, it’s actually not inconsistent for both of these to be facts:
      1) women face structural challenges to their becoming CEOs, that are tougher than what men face
      2) having a woman as CEO gets a company attention

  10. Alex G says:

    That “Helena” thing was an excellent find, Derek

    1. loupgarous says:

      I look at that guy and think “Dubya sure missed out on a good thing.”

  11. anon the II says:

    As an organic chemist with more than a passing interest in various things analytical, I was certainly pulling for Ms. Holmes. There’s been little exciting in the diagnostic world for many for the assays that Theranos proposed to run “reliably”. The almighty SOP allows little room for innovation and the industry has been consolidating around companies that make money by scaling it up and buying out any competition (and raising prices). Not very exciting. Unfortunately, the Theranos story always sounded a little too good to be true. It was always difficult for me to understand how someone so young could grasp all that was required to compete in this space. Turns out, it never happened. I’m not mad, just disappointed.

  12. Magrinho says:

    @Dr Manhattan –
    The Board meetings must look like the House of Lords – lots of old, white heads nodding off.
    How many of them remember what they ate for breakfast?

    Unlike math, music or writing code, there are no prodigies in medical research: it is ‘first principles’ + experience + discretion + … Complicated.

  13. The element of this whole story that I am still not understanding is how, even if Theranos technology worked as advertised, it would be “disruptive” to health care?

    Laboratory testing is not that big a fraction of health care spending, and for most people, most of the time, laboratory data are not decisional. So what is they can use a drop of blood? So what if people can obtain laboratory results without a prescription?

    I never understood it. Still don’t.

    1. Hap says:

      If you can get lab data more quickly and easily, you might get it more often and earlier; for some diseases (cancer), having early diagnostic data would make untreatable cancers treatable by preventing them from getting to where we can’t help, and you might be able to find out useful things by the ability to get lots of data.

      Having more and broader diagnostic data might disrupt treatments for advanced cancers (because you could cut their market), but I guess I don’t see either how it would disrupt medicine in general, since someone still needs to interpret and understand the data, and have something to do about it.

      1. Derek Freyberg says:

        But the point of the Theranos technology was not (far as I know still is not) speed of answer – it was always about fingerstick versus venipuncture: Holmes doesn’t like venipuncture and thinks that other people don’t either. The samples still go off to a big lab soemwhere (Newark CA, Phoenix) to be run.
        The whole fingerstick thing is what made me wonder whether this would ever be attractive – I’ve had fingersticks and venipuncture, and I prefer the latter, as fingertips have lots of pain sensors and the antecubital area has few. And there’s the whole issue of tiny sample size, and whether that too is a feature or a bug.

        1. Hap says:

          Sorry. I Dunning-Kreugered myself.

          1. tangent says:

            … can you do that, and know that you’ve done it?

          2. Hap says:

            I don’t know, but if someone else knows that I didn’t know what I was talking about, then I can conclude that I didn’t and should be quiet. Knowing that before I talk….

        2. HT says:

          Excellent point. I am also sure that any patients (e.g. DM) who’d experienced both would significantly prefer venipuncture over needlestick.
          Allowing everyone to get diagnostic tests without indications is an even bigger problem. Every test has a certain false-positive/ -negative rate, and the quantitative ones have “normal” ranges. It is difficult enough for doctors to order the proper panel of tests and correctly interpret the results in every situation, and to make these tests accessible to everyone is a bane not boon to healthcare.
          So … Theranos being a fraud is perhaps the best outcome after all?

          1. Ed says:

            Neo-nates in ICUs would certainly disagree – many are punctured so regularly that it very quickly becomes near impossible to find usable veins.

          2. tangent says:

            Adding on to Ed’s point: NICU babies sometimes need transfusions to make up the blood volume drawn for testing. Granted, many would need a transfusion anyway before their bone marrow gets into gear, but some would skate through to there if it weren’t for the blood demands of the daily panel.

            Not sure if blood drawn from a capillary bed would even do it for NICU, but the low-volume aspect would have a real application, though a niche one.

        3. Sam P says:

          Apparently my veins are hard to get at, it’s always been an ordeal to get a blood sample from me. The nurse (or whoever) typically spends over a minute sticking and resticking a needle into my arm, more than once I eventually fainted (psychosomatically I guess). I’ve attempted to donate blood twice, both times unsuccessfully, there won’t be a third attempt. If a fingerprick was enough for a test, I’d definitely prefer it.

        4. HFM says:

          I agree with the discomfort factor of finger-sticks. I give blood regularly, and while the large-bore needle is mildly unpleasant, the preliminary finger-stick to check your iron is the one that still bothers me hours after the fact.

          But I suspect that finger-sticks have a significant advantage in ease of use. To get a blood draw, you have to go to a facility and see a trained phlebotomist. Finger-sticks could be done by anyone…heck, they could probably just put one of those poky things in the test kit and let you draw blood yourself. There’s a real cost and convenience win there…if it works, of course.

      2. loupgarous says:

        I have to side with “angry cardiologist” here. So what if you can run a panel of lab tests with a fingerprick sample you mailed in? Does the average person know what to make of out-of-normal range clinical lab values? I had human physiology as an undergrad studying biomedical engineering (mumble years ago), and I’d have to crack my copy of Ganong, and possibly my five-buck (used at the LSU School of Medicine bookstore) copy of the Manual of Medical Therapeutics to have a rough clue what some of those values meant.

        I don’t agree with the authors of the JCI paper that Theranos would necessarily change health care utilization patterns, because any clinician with good sense would repeat those tests through a lab service she trusted before prescribing medication or referring someone for specialty care.

  14. oldnuke says:

    “Disruptive” is just another trigger word for dumb investors like “paradigm” was a while back. As soon as someone throws that word out in a meeting, I think of small children throwing tantrums in preschool. Now THAT is disruptive! 🙂

    1. Nick K says:

      Precisely. A technology doesn’t have to be “disruptive” to succeed.

      1. Hap says:

        Disruptive tech is supposed to change the market (or remake it) in a way that gives it a decisive advantage, like guerilla warfare when you’re dominated by large well-equipped armies. Investors and companies don’t want to play in competitive markets – they want markets where they will win and win big. It also implies (?) that the business outcome is not predictable by the rules of the previous market – if history is not relevant, then it removes a lot of the need for evidence based on that history. Hence why investors and companies love “disruptive” – it’s like “artisanal” for food.

        1. Phil says:

          And sought by the same people that ask others to try and predict the next “black swan.”

  15. Zander says:

    The story of Theranos starts to remind me of the inventor John Ernst Worrell Keely from the 19th century, who also claimed to have discovered how to harness the energy from the ‘interatomic ether’ and attracted a lot of money from investors, without ever publicly displaying his technology..

  16. watcher says:

    Having read before about Holme’s leaving Stanford short of a degree to start a company with a “great idea” made me shake my internal head (did not want to rattle my brain). The idea might actually have been a good one (although the approach is not absolutely novel), but the approach from the get-go was terrible….over-promised and oversold She has demonstrated a great amount of over confident naivete. What they need for this to work are smart, clever analytical persons with experience working in a regulated environment. No one associated with them has had these qualifications, which doomed the approach from the start. Can they recover? Perhaps. But it will require that assays for each and every analyte be validated, qualified and compared to existing approaches. It would be a long, expensive and time consuming endeavor to ever see positive cash flow; not the quick path to fast riches envisioned by so many.

  17. Curious Wavefunction says:

    I was always flummoxed by Theranos since I never understood what they really did and why it was so big. It clearly seems I was not alone in thinking this way. To a large extent the Theranos story illustrates the pitfalls of young people growing up in Silicon Valley and thinking that they can revolutionize healthcare the way Jobs and Gates revolutionized software. Wetware is simply unlike software, and that’s not going to change anytime soon.

    Elizabeth Holmes still sounds like a smart and ambitious person to me, and I hope she can get her act together (god knows we need quick and comprehensive diagnostics, especially for developing countries) but she seems to have fallen for Feynman’s dictum: “The first thing is to not fool yourself, and you’re the easiest person to fool.”

  18. skip14 says:

    I work in point of care testing and have followed Theranos for years. Based on the number of assays the Edison instrument supposedly performed, over the full range of hematology (CBC), chemistry (Na, K, Cl), immunoassay (thyroid hormones), and coagulation, it was certainly a too good to be true story. Too many assays requiring diverse technologies all in the same box working on a tiny sample.

    I can appreciate the business model, upfront pricing and not selling the instruments. No prescription gets the health anxious folks who can test w/o health insurance reimbursement. A nice app to track your tests, what’s not to like.

    Perhaps she can open a shop for CNC machining. Frequent images show rows of machining centers, at least 14 by my count in the picture with Joe Biden, 4 million in capital hardware. Unfortunately chips are not spewing out of the conveyors and raw blocks of aluminum or finished parts are nowhere in sight. I don’t know of a diagnostics manufacturer that would invest in machining equipment when the work can be bid to shops. It shows either paranoia regarding your IP, or overboard planning for a rapid product launch. Either way its not a core function.

  19. Anon says:

    I wish I could bring myself to lie and delude myself and others so effectively. Then I might be able to pay my rent, let alone become a billionaire, even if only on paper for a short while.

    1. Mark Thorson says:

      Scientology can help you with that.

  20. Peter says:

    “And how long will it be before investors line up again to throw sackfuls of money at a 19-year-old with a big biomedical idea?”

    A well-connected, wealthy, attractive and blonde 19 year old, with a year of college, and absolutely no experience in the medical testing field. Folks, optimism is wonderful, but at some point in the process, the rubber has to hit the road, as they say.

    In this case, not only was there no rubber, there were no wheels and the engine appears to have been built by some clown who threw out a bucket of “extra” parts.

    I have little sympathy for those who lost money investing in Theranos. They should have seen the signs and known better. I hope no patients were injured by their shenanigans.

    1. A says:

      The part of this story that interests me is how the whole thing got started. Peter, was Elizabeth Holmes “well-connected” and “wealthy” before starting Theranos? That would go a long way to help explain things. Or was the “attractive and blonde 19 year old” with a good idea somehow enough to get things started?

      1. Derek Freyberg says:

        Certainly well-connected: you can go back to the October 2015 stories and get more background there. Not wealthy as far as I know.

      2. Robert says:

        According to her bio on Wikipedia her father worked for USAID and her mother was a congressional staffer. She also spent a year at Stanford, which was paid for by some sort of trust fund.

        So, Holmes was well connected through her parents in addition to any professors she impressed at Stanford. Since she drew on a trust fund in founding Theranos I’d guess she was a 1%er though not a .1%er.

      3. artkqtarks says:

        The following New York Times and New Yorker articles below describe more about her family background. Her family is certainly well-connected. She is related to Charles Fleischmann who made fortune by founding the Fleischmann Yeast Company. As the New Yorker article discloses, this also means that she is related to one of the founders of the New Yorker magazine.

        http://www.nytimes.com/2015/12/20/business/theranos-founder-faces-a-test-of-technology-and-reputation.html?_r=0

        http://www.newyorker.com/magazine/2014/12/15/blood-simpler

  21. Scott says:

    There was so much smoke that there had to be fire. I remember reading a Fortune article about her last year and sensing something was fishy. What I don’t understand is how they could reach a valuation on private placement of $9B. The two behemoths of the market, Lab Corp and Quest are only valuated at $12B and $10.5B respectively based on real revenue. You can only change the paradigm so much in a regulated industry.

    1. Sam P says:

      That’s actually the simple part. If a private investment of $x buys y% of company, then that implies a valuation of $(x * 100 / y). The investors were probably wrong about the true value, but that’s the valuation in the absence of a market.

      1. tangent says:

        May have been misleading rather than wrong… You’ll see investors buy in to a company at a valuation that they know is too high. They’ll do it to set that wild valuation, rev up hype, and bubble the price upwards so they can sell at a profit later. And they’ll do it when they’re in bed with the founders — not that the founders are even planning to sell off their shares, but this valuation lets the company raise further money at a lower price in equity.

  22. Wallace Grommet says:

    Having a company name that sounds so much like Thanatos in the health care technology field? Talk about Freudian slips!
    Love the Helena Group link and this comment from the article author trying to figure out what the skinny:
    “In a state of desperation, I did the thing I swore I’d never do: I asked the company’s public relations team for help. Asking a corporate PR squad for simple, concrete, spin-free facts is an almost sadomasochistic experience, but what else was left? “

    1. Design Monkey says:

      There also was radiation therapy machine Therac-25, which was involved in notorious radiation accidents and patient deaths.

      1. loupgarous says:

        Slightly off-topic, but speaking of Therac-25, six years ago there was another cluster of death and disability stemming from bad software and operator error involved with automated radiotherapy (this time, the Varian Medical Systems Intensity Modulated Radiation Therapy device, a linear accelerator depending on a leaf collimator to localize radiation dose to the intended therapy site – which depended on alert operators not to deliver fatal or disabling doses of radiation to patients.

        The common denominator here being pseudovalidation of a process by computer (I assume that in Theranos’ case, when results of these lab panels go sideways crazy compared to boring old venipuncture-collected samples run through tedious calibrated benchtop lab gear, a computer will be handy to blame for the issue).

  23. Kaleberg says:

    If you follow finance, so much of the money is driven by fancy Powerpoint briefings. In finance, everyone knows everyone else, so getting big valuations and lots of startup money is basically about convincing one player. Everything flows from there.

  24. Ronald says:

    @Kaleberg
    Sadly enough, my experience with finance in biotech is exactly the same. Major pharmaceutical companies, investment bankers, VCs…follow the hype of the moment (microbiome, immuno-oncology,…). Some of these ideas are just ludicrous: any undergraduate with some critical skills would tear the story apart.
    The ‘investors’ all seem to know each other also – very strange. The sad thing is (as mentioned very often on these pages) that good money is wasted on silly projects, while sound projects wither because of underfunding. For example, groups in major pharmaceutical companies who identified good targets have to fight for funding, while the company spends money on outsider projects that will only fly on powerpoint wings.

    1. Andre says:

      Ronald, I could not agree more with your assessment. I have had the same experiences over and over again. Academic sources funding is too small for big, large-scale approaches and big pharma funding is driven by hypes and me-too-type projects. The last hope is to find benefactors that are willing to fund unconventional projects. If know of an Elon Musk or Bill Gates let me know….

    2. Phil says:

      “The ‘investors’ all seem to know each other also – very strange”

      The perfect scenario for information cascades and groupthink.

  25. Anchor says:

    Hi this is Kevin Trudeau and I appreciate the fact that Liz Holmes is following my example. Can’t fool all the people all the time!

  26. Earl Boebert says:

    Well, I don’t know squat about blood tests (except that I’m of an age where I await the results of mine with apprehension) but I was the Chief Scientist of a fairly successful tech startup and the Theranos affair seems to me to be very strange indeed. There’s nothing inherently wrong with having a rock star inventor/CEO as long as she or he is backed up by a strong Chief Operating Officer (AKA the inside person) who knows how to keep the wheels on the rails. Also, from what I read the young lady and whoever was advising her fell for the current biz school/management consultant/MBA fad of organizing your company into highly independent units whose leaders could run however they wished as long as they met their financials. This is a cool way to run something like an ad agency, where there is a great potential upside to flexibility and the downside to screwups is limited to your bottom line. It’s a lousy way to run an operation where screwups can kill people. That’s where the (evidently nonexistent) COO comes in.

  27. Jose says:

    I keep wondering if all the new regulations for Uber and Airbnb plus this Theranos-cluster are the leading edge of the second big Silicon Valley bubble popping?

  28. Old Lilla says:

    I feel an update coming.

    “But now things have reached what may be the worst stage”. No, I think it gets much worse from here.

    1. loupgarous says:

      On July 8th, the Centers for Medicare and Medicaid Services forbade Holmes from running a clinical lab for 2 years and from taking Medicaid and Medicare payments for clinical lab services (this after Theranos assays for blood warfarin levels were consistently off).

      And just now, the first hedge fund has sued Holmes for misrepresenting Theranos.

      So yeah, your feeling was accurate. The worst is yet to come. But she’s what, 20? People have come back from worse train wrecks than this.

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