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The Beginning Of The End For Theranos?
It started off as a bad enough day for embattled, recently notorious, biotech startup Theranos, which after a series of reports by the WSJ has found itself, and its $9 billion valuation, reeling.
First, the Verge reported citing New Yorker, WaPo, Economist and Fortune, that according to Theranos, it "earns a portion its income from large pharmaceutical companies Pfizer and GlaxoSmithKline, who reportedly use Theranos' tech to conduct clinical trials. But according to representatives from both companies who spoke to the Financial Times that information is factually incorrect."
"I cannot find any evidence that we've done business with them in recent years," a spokesperson for GSK told the Financial Times. Pfizer, on the other hand, said that the company's dealings with Theranos were limited. "We've done only very limited historical exploratory work with Theranos through a few pilot projects," the Pfizer representative said, "and we do not have any current or active projects with them."
Embarrassing yes, but hardly fatal: if the company has survived the recent spate of bad publicity, then its deep-pocketed backers will certainly ignore this latest discovery.
Much worse was the news released later in the day when in a Form 483, released by FDA, it was unveiled that the very heart of the company's business model, its 'nanotainers', or as it is also known as a Capillary Tube Nanocontainer (CTN) are essentially unacceptable for use.
For those unfamiliar, this is what a Form 483 is:
Q: What is the purpose of an FDA Form 483?
A: The FDA Form 483 notifies the company’s management of objectionable conditions. At the conclusion of an inspection, the FDA Form 483 is presented and discussed with the company’s senior management. Companies are encouraged to respond to the FDA Form 483 in writing with their corrective action plan and then implement that corrective action plan expeditiously.
Q: When is an FDA Form 483 issued?
A: An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. FDA investigators are trained to ensure that each observation noted on the FDA Form 483 is clear, specific and significant. Observations are made when in the investigator’s judgement, conditions or practices observed would indicate that any food, drug, device or cosmetic has been adulterated or is being prepared, packed, or held under conditions whereby it may become adulterated or rendered injurious to health.
Here is what the FDA said today:
"You have not listed the [Capillary Tube Nanocontainer] as a Class II medical device, and you are currently identifying it as a Class I exempt medical device. You are currently shipping this uncleared medical device in interstate commerce, between California, Arizona, and Pennsylvania."
Is this transgression bad enough for the Feds to step in? We may find out very soon.
To be sure, today's FDA finding repeats what the WSJ had reported previously, although it is now clear that Theranos lied once again, explaining that its halt of the Nanotainer had been a voluntary decision, when it clearly was mandated by the FDA. From the WSJ:
The FDA inspection confirms an article published by The Wall Street Journal on Oct. 16 that said Theranos had stopped using the vials for all but one test under pressure from the agency, citing a person familiar with the inspection. After the Journal article, Theranos founder and Chief Executive Elizabeth Holmes confirmed the company had sharply curtailed its use of the vials, which it calls nanotainers, but presented it as a voluntary move.
That's ok: she lied again, something which appears to have been a recurring pattern for this 31-year-old paper multibillionaire. Sadly for her, following these escapades, "on paper" is where her young billionaire status will remain, as we doubt anyone, either in the private market, and certainly in the public one, will bother to invest even $1 more at a valuation anywhere approaching $9 billion, or even a valuation of $0 for that matter.
As for Theranos and its young founder, we wish them luck with pivoting from a company that has problems with keeping the story straight, to one that has actually cash flow. It will need it.
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if all fails, They should manufacture meth for our friends in the mid east..
Beirut: Saudi Prince Held After Amphetamine Seizure
Easy ... sell it to Yahoo! for billions, buy a sports team, then do a TV show telling people how much they suck at business.
Duh!
Regards,
Cooter
Making statements "that are factually incorrect"
I heard a libtard commentator describing Hillary's various testimonies and statements this way as well.
Another way of saying someone is making "factually incorrect" statements is to say "They're LYING !"
Who edited this article? Stevie Wonder?
GMOs get a free pass from the FDA but Capillary Tubes are a show stopper?? Come on, that doesn't make any sense unless some power brokers want to stymie Holmes' vision of cheap, fast, and reliable testing accessible to people everywhere without having to get permission from the Medical Industrial Sickcare Complex.
Top politicos courted Holmes like royalty when her business model emerged. The Theranos board includes such luminaries as George Shultz and US military brass. That's a big clue to the kind of straight jacket the Masters of the Universe wanted to put around Theranos.
God forbid we should take charge of our own health and escape TPTB's model of Orwellian Technocratic Hell.
Stupid 30 year old kids running multi-billion-dollar companies thinking they can lie like the big boys, but neglecting to pay the required tithe to the emperor for the right to do so beforehand.
That was the first thing that popped into my head - she either forgot or didn't know to grease the right people. Pay to Play is the Only Way in the USSA.
There-A-Noose?
Naw, not enough grease on the proper wheel.
T-her-anus
Funny sounding company name.
"The End For Theranos?"
"Micro titration" "Microfluidics"....
The elephant in the room?
Why the 483? Thanks to the former admin (not that Barry is better), the FDA has to be "funded" largely by the top 20 pharma companies.
You can't "regulate" the hand that feeds you from "fees".
The FDA (speaking from industry experience) is there to "promote" the industry (top 20 FDFs) and thus acts accordingly.
Any "free market" competition is squashed like a small "micro" bug.
For this being a site about "economics" there sure is little knowledge about "monopoly" capitalism.
And 60 year old entrenched management teams running multi-billion dollar buyback frauds are better? This has nothing to do with your dumbass zionist gimmick NoDebt. Go chase some Muni's with the Doubeline guys.
Thermanos was a company who had the right hookups and tried to sell a sow ear as the next big thing. Microtitration and micro-analytics have been around for at least 40 years in chemical engineering. Her idea of using digital sensors while new to some, does not get around sample error bars, which are a fact of physics and can not be handwaived away no matter which CFR guy you have on your BoD. The jig is up and since 80% of the company is goodwill on unproven tech, it will likely be sold for scrap. Which is what happens often in failing market peaks. Her tech failing to deliver is just a sign of a rational market endgame.
In her defense, had the tech managed to work successfully then average bioscience lab times would have fallen by 60%. Had she stayed in stealth mode until FDA approval and underpromised on the 120+ testing suite after Series B, she would have had a fighting chance on a pivot. Now she's shark food.
Little sand in your vag, Rat? What the fuck did I do to you?
I'm sure her Stanford pedigree helped a buttload.
And yes, microfluidics has been around forever. First thing on my mind when I first heard about Theranos was how accurate was their data? I've worked in microbiology labs as a PhD before I went into nanomaterial fabrication. Biggest problem was always the accuracy of the data. Especially when dealing with biological samples in the range of micro-liters.
Holmes is learning the hard way what a proper education could have taught her: you can't fuck with physics (yet). The tech just isnt there to detect a few specific molecules in a sea of water/blood. ESPECIALLY in biological cases. We can't even isolate all the bacterial/fungal strains in a dirt sample, since there is a whole ecology we know nothing about, and it varies greatly from area to area. I would expect this is the same case with blood: it varies greatly from person to person, but also from area to area. if you dont take a large enough sample, youre essentially getting a 'snapshot' of some specfic part of your body with a huge amount of error in testing. Hence, the crap values Theranos gives you that change up to 40% based on when/where you take them.
Microfluidics IS great at predicting the PRESENCE of certain molecules. But not the constituent concentrations.
Hope Holmes is using the 9 billion for intensive R&D.
I was first surprised you hadn't gotten more up arrows, but the primarily Luddite group of ZH posters tuned out at "microfluidics."
I upvoted him or her because they are right about Stanford. In Silly Con Valley - you do not get funded usually unless you are connected to Stanford or the CEO figured head is Stanford.
Daddy is USAID ... CIA ... cough, cough.
Jeez what about the scary eyes?
https://i.ytimg.com/vi/L_J-aNx1lEU/maxresdefault.jpg
Is she auditioning for 'stalker girlfriend from hell'?
Well thanks I guess.
Yeah, Evan Spiegel is another great example of how having your grandaddy donate a wing to Stanford ensures:
1. You're admittance
2. Being able to hype up a completely useless app and make billions
Hey Rat, you back from the dead ... You got some dirt on Hilliary for us?
Well put.
Works for Elon Musk but he is tribe.
Jeffrey Katzenberg crashed his Tesla yesterday and broke his arm. He said Elon Musk saved his life. Lots of people get in car wrecks with cheaper cars and never get hurt. Shame katzenberg's neck was not broken.
Technology that offers a comprehensive blood test for $4.95, neglecting insurance companies all together is not going to generate enough profit to cover the bribes.
Wait, you think she's actually running the company? Nice one!
She's likely just the poster child for an elaborate scam. Any money she might have made in an IPO would have probably been used on "strategic acquisitions" of her puppet masters, errr I mean "competitors".
The shit is called Captagon.
http://www.liveleak.com/view?i=ab6_1444833843
Someone in the US Army told me that US troops fighting in Fallujah and other places were given a supposedly safe and non addictive version of meth to stay awake for 3 days. Anyone know about this?
Addiction is an interesting term. I guess if one only takes heroin for 3 days they will not be addicted... but 4 days, that's different. If one can stay up for 3 days, I assure you, that is very addictive.
OK, there is something I should mention here. I few years ago I started following a biotech company due to a personal interest in a product they had under development. As I read about them, I was surprised to learn that the original scientists who had invented the product had left the company. I presume they were replaced by more "accountant" type executives. Things started getting really strange. For example, they were talking about increasing the doses of medicine they could manufacture from a single source sample by a large factor in order to increase profit margins. That sounds great, but the problem was the medicine didn't even work yet and that kind of tinkering only made it less likely to work. And they did many other things along those lines.
So, they finally conducted tests to get FDA clearance and guess what. The medicine was a total failure. Guess what became of the company? Yep, they got a multi-billion dollar contract with the US military to supply some other crap they were working on.
Draw your own conclusions about what these companies are all about.
query: Osiris Therapeutics
The company did not grease enough palms in DC evidently.
delete
If it was a man running this company, they would've been subject to proper due dilligence and never been funded in the first place
Now that is some funny shit right there...nice inversion with a touch of meta
Somebody said her dad's a CIA dude, so you figure some stings woulda been pulled. But she's not cho zen
so I figure her business model will be adopted by a "deserving" entrepreneur ala-- Winklevoss.
+1
White privilege on the march.
Yes - because all white people have ties to the CIA, Bohemian Grove, BIS, and the Stonecutters Weight Room - be they lion-killing dentist or Appalachian dirt farmer.... due to their whiteness, they have all sorts of advantages over the long-oppressed African-Scandinavian people.
Tell us, Eirik, why you haven't returned to the lands of your ancestors, to help them understand the nuances of running water and the wheel?
fucking white chicks in "civilization" sure is more fun, ain't it?
Jews aren't white.
Ashkenazis are.
The small Med, Bio-Med & Insurance Companies continue to get picked off. In this case, it might just be legit.
Still, the weak continued to be culled. Financial Darwinism in action.
'
'
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The BreX moment for Theranos?
•?•
V-V
Did the COO fall from the helicopter, never to be found?
Almost as good as ZzzzBest carpet cleaning.
A female Barry Minkow.
Big Kissinger no happy
SERIOUSLY
I'd advise Ms. Holmes to avoid any and all light aircraft flights in and out of SJC or Palo Alto municipal airport.
Also, STAY THE HELL AWAY from the power tools aisle at the East palo Alto Home Depot.
I had a really cool Scooby Doo lunchbox when I was a kid and it had a matching Theranos inside.
I never had a lunchbox. I was the brown bag kid with a peanut butter sandwich. Now I'm the brown bag grown up with a bottle of Boons farm.
Ahhh, with the apple on top of the PBJ to make the bread purple and soggy by lunch?
Fun times.
pods
Yep you know it.
my broker told me twice ive got nothing to worry about...
i didnt hear the first time as there was too much laughter in the background...
A CEO lied? More there is a shocking development never seen before. My guess is like the previous poster said, she didn't pay off the right people. Either that or Theranos is being taken out so they can be picked up on the cheap.
Again...and...again...and...again..."But if WOMEN were only in charge everything would be different"...How many damn years I heard that mantra from every two-bit, brain-dead feminist...The reality, as I stated over MANY years: There is NO difference between men and women when it comes to morals, ethics, integrity, etc...
Jane Fonda calling....
I will volunteer to spend a night with IT at The Hanoi Hilton...However, I will also make a promise...That COCKROACH will not be checking out in the morning.
And Fonda then turned around and is kissing neocon ass. How times have changed!
calpers will buy it
Better planning would business/bundle with RiteAid.
RiteAid is getting $9/share from Walgreen.
Maybe some sugar daddy will bail her company out.
T-her-anus might have escaped what will surely follow..in the end, ouch!
A biotech company founded by someone who has no background in medicine or biotech is struggling to make biotech products? Really?
When will a company founded in 2003 cease being a startup?
When it no longer gets people excited? Sadly, it's gone from startup to startend before it even had a chance to do the middle, "legit" company thing.
All about what sounds good, entrapment of cheap money...
Obviously she should have draped herself over some lawn furniture for Vougue
Actually seems like administrative bullshit - the FDA flexing its muscles, because a container is called a "medical device" which must be approved as part of the {A}NDA, etc.
Basically, the issue is the FDA says the medical device - that is, a small storage device which may or may not be properly categorized as a "medical" device was not FDA approved during a site inspection.
As the form notes "your firm is responsible for conducting internal self-audits,..."
I don't think the CEO was lying here. Also, and I've only worked on the periphery of pharma re patent stuff and essentially product liability/failure to warn stuff so I will defer to someone who knows this stuff better - but these FDA complaints look like small potatoes to me.
Class I devices are things like dental floss and bandaids. Little risk. If Theranos is claiming that they do precise blood panels and other tests with amounts of blood smaller than existing tests, with new types of reagents or sensors (lab on a a chip type arrangement) the FDA may be saying they need to prove their accuracy/sensitivity/specificity. They may not be willing to accept CLIA waiving standard tests done in a new way. Plus, fucking with the FDA is typically unwise-like trying to speed to market and get around regs by intentionally misclassifying a device. If they had really spectacular results across a wide array of tests, I'd think they'd be shouting it from the rooftops. It smells like when the military classifies technology because it DOESN'T work well so no one knows its a fail.
Yeah, Theranos classified the tubes as a Class I exempt device, whereas the FDA classified it as a Class II.
They probably classified it as such because it had little to no contact with the patient. FDA saw it differently. Not sure how it is used but if it does contact blood they might have a hard cutoff as to whether it is a Class II or not. It could introduce stuff to the body easier and therefor be a Class II device.
The audit thing is a bigger one, but Form 483 isn't what it used to be back around the Barr Labs thing.
Pretty much the FDA letting them know who's boss. Not sure if there is any malice or just bureaucracy.
Either way it just torpedoed their company.
pods
if this sinks them, that's too bad, presuming they weren't looking just to cut corners.
I'm a little surprised it's as bad as it apparently actually is, granting, again, my very limited knowledge and understanding re FDA and med device and drugs.
I can only suggest that at least for certain drugs, the list of observation violations could be somewhat lengthy.
I would guess that a lot hinges on intentional versus oversight, and substantive versus administrative fuck ups.
I thought she was the new Steve Jobs? what gives ...
She did have the black turtleneck look down. That gets her halfway there.
I think her voice is deeper ...
Yeah - she looks like a hybrid of Hillary and Chelsea and dresses like a hybrid of Jobs and Larry Ellison.
She didnt have a wozniak...
Thank heaven they still approve of cryotherapy. What would do without that?
http://nypost.com/2015/10/26/woman-froze-to-death-in-cryotherapy-chamber/
Another case of people who think they know more than they do (investors) throwing money at something they don't understand. So now the investors are stepping back and letting her twist in the breeze. If you watched that WSJ interview she was clearly bullshitting.She didn't have enough experience and the company doesn't have anything tangible to demonstrate. Perhaps there is time for her to cash out some, buy a really expensive house in Cali. Then she'll have something to trade with after this all goes to shit.
Yeah, investor FAIL here. Lack of due diligence. Sore losers are making sure she gets publicly flogged. Similar in lots of ways to Bernie Maddoff's dealings.
the container hassle is the fine print that is killing them today. the reason their future is screwed is that the much-promised machines which were supposed to be able to do many diagnostics on tiny samples apparently just don't work. ain't gonna be easy to get around that.
http://www.gettyimages.com/detail/news-photo/billionaire-elizabeth-holme...
Here is a picture of her at some Obola (police) state dinner. She looks like a Hillary Chelsea hybrid - no thanks. If she had a nice rack it might help.
Other scum bags at the dinner were amnesty Paul RINO Ryan and Sulu aka George Takei, who brought his husband.
This really isn't news, most Biotech's like the Internet tech bubble have been running scams for years...It just seems like this are now coming to the head of the pin...
Theranos founder and Chief Executive Elizabeth Holmes .....zero tits, wide load, would bang.
Thank you for the executive summary
https://www.linkedin.com/pub/ian-gibbons/23/553/127
She's obviously a reptile.
this is a prescient quote from otherwise rather glowing article, Fortune 6/12/2014:
If Theranos is making breakthrough analyzers, they wonder, why doesn’t it just sell them to existing labs? To these critics, for Theranos to compete in the lab business itself while making all its own analyzers sounds implausible, if not crazy–like FedEx trying to manufacture all its own airplanes and trucks.
Now we know why. It was scam all along.
Fortune is a shitty mag. Aka Time Warner. They love crony facist Buffet and obola.
how can I start a scam like this....
This is complete regulatory bullshit. I can't see how this is a Class II device. It never enters the body. It holds fluids removed from the body. To the extent it's got a needle, and I don't know if it is, I can't believe something as trivial and ancient as a needle puts this in Class II.
The FDA must be getting a lot of pressure from LabCorp and their ilk.
I can't see how this is a Class II device. It never enters the body.
I guess a dildo is classified as a Class II device then, right?
Cute chick. Hope I'm on the same shower roster as her in the big house.
She's definitely not cute. Not unless you're Stevie Wonder.
Also, have you heard her voice? That shit'll make a viagra and cocaine infused boner fall faster than WTC7.
That shit'll make a viagra and cocaine infused boner fall faster than WTC7
10 up-votes for line of the week!!! LMFAO!!!
I don’t understand why Theranos doesn’t make a huge donation to the Clinton Foundation, a similar donation to Hillary’s campaign, and hire Bill to speak at their next shareholders meeting for a $1 million fee. All this shit will blow away overnight and by this weekend they’ll be shipping ten million nanocontainers to save the children of poor South Americans and Muslim Imigrants into Europe.
If Hillary is elected the Feds will give Theranos a $500,000,000 loan so they can straighten this all out.
You can't get a job at this company without having a final interview with this chick and/or the the CSO. The ultimate in micro-mismanagement. And they haven't been meeting with people in certain departments for the final interview for months. Although if you look at the website they have nemerous jobs advertised, some recent ones in Clinical. So maybe they are trying to bring in some new people. Good luck getting them to jump onto this sinking ship.
I am very glad they ended up not hiring me a couple of years ago. I was disappointed at the time. Not now.
Did you have to interview with Skeletor? I hope you brought her a snack.
Read the company reviews on Glassdoor, they are a mix of damming condemnations mixed with obviously fake, glowing reviews written by their HR/PR folks.
delete
aha! the goldman 6 million lines of transcripts defence!
http://gizmodo.com/theranos-ceo-agrees-to-publish-data-proving-reliabili...
I don't know much about those tubes but I really wish somebody would feed that woman a cracker of something. She looks like she could keel over from starvation, her neck is the size of a pencil and everytime I see her picture I just cringe. Steve Jobs looked healthier recently.
It's been months since I've driven past the brand new HQ building being built for Theranos on Pagemill Rd. in Palo Alto. Must be costing them a small fortune with expensive real estate like that.
Wonder if it's finished... or if they'll ever move in.
You should see the new building across the Dumbarton bridge in Newark. Tons of space. No sign outside to let you know the company is even there. Because everthing they do is SUPER SECRET. Although you can read their patent applications freely at USPTO.com. Microfluidics, centrifugation, UV detection. Yawn. Newsflash: Abaxis has been doing this tye of testing for 15 years, they use 2 drops of blood, have an approvd device with 15 minute turn around on their device (which is $8k) and they do a lot of tests (glucose, Total protein et cetera) No one talks about this though, what Theranos wants to do is already being done (except the nanotainer thing which isn't working out so well) Also Abaxis is a public company already.