Unless they believe that they could cheat or bribe the FDA.
What makes them special? Large pharma companies tend to lose billions of dollars in valuation when a promising drug fails FDA trials—clearly, they are unable to “cheat or bribe” the FDA.
But going back to Theranos, I believe the problem they ran into is local variance: when you analyse tiny amounts of blood, two samples from the same blood draw end up with very different measurements for some quantities of interest. You just need a larger sample and that is a big problem for Theranos.
But going back to Theranos, I believe the problem they ran into is local variance: when you analyse tiny amounts of blood, two samples from the same blood draw end up with very different measurements for some quantities of interest. You just need a larger sample and that is a big problem for Theranos.
I think that’s an issue but Theranos tests don’t need to match existing tests in accuracy to be useful in a clinical setting.
Both blood to be drawn from veins and money are limited resources. If Theranos can mange over time to test two orders of magnitude cheaper on both resources then you circumvent the problem of local variance by testing multiple times.
Testing multiple times has the advantage that you can circumvent temporal variance as well which current testing procedures don’t do well.
Multiple tests also give you data about the local variance and the size of the local variance is plausibly a clinically relevant number.
What makes them special? Large pharma companies tend to lose billions of dollars in valuation when a promising drug fails FDA trials—clearly, they are unable to “cheat or bribe” the FDA.
What is your point? If Theranos is a scam, then it wouldn’t be the first scam operated by overconfident people, or just people with very little risk aversion.
How could Bernie Madoff run a massive Ponzi scheme right under the SEC’s nose without expecting to get caught? Well, he did it anyway, and in fact he managed to get away with it for perhaps decades, and if it wasn’t for the 2007 financial crisis, I’d bet he would be still running it.
But going back to Theranos, I believe the problem they ran into is local variance: when you analyse tiny amounts of blood, two samples from the same blood draw end up with very different measurements for some quantities of interest. You just need a larger sample and that is a big problem for Theranos.
Maybe. I don’t know anything about blood testing, so I can’t evaluate their claims at object level. What I know is that their business consists in a product based on an alleged technological breakthrough that they were never been able to conclusively demonstrate. And they are trying to sell to non-experts who aren’t able to evaluate the quality of the product that they buy.
How could Bernie Madoff run a massive Ponzi scheme right under the SEC’s nose without expecting to get caught?
He didn’t invite the SEC to audit him. Theranos did invite the FDA. The FDA audited them and found issues where they think Theranos has to improve and Theranos plans to improve on them. That the system working as it should.
It’s not a problem for Theranos business model that they will have to add a few extra processes to raise quality. The system is working as it should.
What I know is that their business consists in a product based on an alleged technological breakthrough that they were never been able to conclusively demonstrate.
That’s because you are uninformed because you believe media that tries to trash Theranos.
To date Theranos got two FDA approvals.
And they are trying to sell to non-experts who aren’t able to evaluate the quality of the product that they buy.
While they do plan to sell to non-experts they want the FDA to be the judge over whether they can sell the product and that also means the FDA will regulate what Theranos can write on the label of the tests.
What makes them special? Large pharma companies tend to lose billions of dollars in valuation when a promising drug fails FDA trials—clearly, they are unable to “cheat or bribe” the FDA.
But going back to Theranos, I believe the problem they ran into is local variance: when you analyse tiny amounts of blood, two samples from the same blood draw end up with very different measurements for some quantities of interest. You just need a larger sample and that is a big problem for Theranos.
I think that’s an issue but Theranos tests don’t need to match existing tests in accuracy to be useful in a clinical setting.
Both blood to be drawn from veins and money are limited resources. If Theranos can mange over time to test two orders of magnitude cheaper on both resources then you circumvent the problem of local variance by testing multiple times. Testing multiple times has the advantage that you can circumvent temporal variance as well which current testing procedures don’t do well. Multiple tests also give you data about the local variance and the size of the local variance is plausibly a clinically relevant number.
What is your point? If Theranos is a scam, then it wouldn’t be the first scam operated by overconfident people, or just people with very little risk aversion.
How could Bernie Madoff run a massive Ponzi scheme right under the SEC’s nose without expecting to get caught? Well, he did it anyway, and in fact he managed to get away with it for perhaps decades, and if it wasn’t for the 2007 financial crisis, I’d bet he would be still running it.
Maybe. I don’t know anything about blood testing, so I can’t evaluate their claims at object level. What I know is that their business consists in a product based on an alleged technological breakthrough that they were never been able to conclusively demonstrate. And they are trying to sell to non-experts who aren’t able to evaluate the quality of the product that they buy.
He didn’t invite the SEC to audit him. Theranos did invite the FDA. The FDA audited them and found issues where they think Theranos has to improve and Theranos plans to improve on them. That the system working as it should.
It’s not a problem for Theranos business model that they will have to add a few extra processes to raise quality. The system is working as it should.
That’s because you are uninformed because you believe media that tries to trash Theranos. To date Theranos got two FDA approvals.
While they do plan to sell to non-experts they want the FDA to be the judge over whether they can sell the product and that also means the FDA will regulate what Theranos can write on the label of the tests.
You said: “Unless they believe that they could cheat or bribe the FDA”. Do you actually have any reason to think this is a likely possibility?
So why did you decide to jump in and focus the discussion on Theranos?