IdoRA

It is important to consider that cash is not “free” to accept and handle (consider the needs for safe storage and depositing, as well as losses due to skimming and other forms of theft). The overhead in handling cash, for some business sectors, greatly exceeds the transaction costs associated with credit and debit cards. An option that preserves privacy but doesn’t have the overhead of cash is needed.

> The new fee structure is applicable to purchases made on Windows 10 PC, Windows Mixed Reality, Windows 10 Mobile and Surface Hub devices and excludes purchases on Xbox consoles.

(italics added for emphasis)

> I can't help but think the founding fathers probably wrote the second amendment with single shot muskets in mind.

The Belton flintlock, a repeating rifle design, was presented in some form to the Continental Congress in 1777. The idea that the founders did not dream beyond single shot muskets is not supported by the historical record.

Did you do a trademark search yet? T-Mobile US had a Sidekick device not long ago and may not have abandoned their registration.

I wonder if we’ll see that shared governance model expand in response to COVID budget pressures? I’d consider that a positive outcome. I haven’t heard any opinions on it in APLU or COGR calls.

Keep in mind that if you're not a professor, you're an administrator. Most university administrators are grossly underpaid relative to industry. Also keep in mind that the mission of public universities is more expansive than education for students.

> Why can't the Dean of the College also handle grants for their college?

Among other reasons: It takes an entire team to manage the lifecycle of grants, it's too much work for a single person to accomplish. In addition to the work needed to apply for a grant, there is also mandatory reporting and compliance to that needs to be completed. Additionally, a dean doesn't have the capacity to bind the entire university to the terms of a grant (nor the awareness to safely do so), so you run into problems with interdisciplinary research, which is increasingly encouraged.

GS wages are adjusted to MSA, so why shouldn’t Facebook do the same?

I demand to know enough information to be able to give proper informed consent to study volunteers.

I think your ideas are possible, but the likelihood of success is quite low and the effort required to do the proper studies is far greater than you estimate. Our resources are better spent on much more developed programs with better defined odds of success.

My helpful closing suggestion is to speak with some epidemiologists and clinical researchers to see if you can get some budgetary efforts for what you propose, or failing that, try to locate a review article or two. Good luck.

Assuming that one located a naturally mild strain of virus (which I personally remain bearish on), for it to produce useful (in the regulatory sense) information a challenge trial, you would need to establish that the response of individuals to the mild strain (which by definition differs from the more lethal strain) is representative of the response to the more lethal strain of virus.

No. The immune system is incompletely understood and staggeringly complex. It’s not a single performer or a band: it’s a symphony. You can examine individual parts to your heart’s desire, but the true nature of the immune system arises in the emergent properties of the system.

Your “first level” is something we already do with primary and immortalized cells and it can be a useful model. Your next level would be called co-culture and it also is something we already do. These can be static cultures or connected to flow systems or bioreactors or whatever. These are imperfect models, but they can help to yield useful answers for questions in the model’s scope. The closest fidelity to human immune systems would be animal models, and the closest of these would be Rhesus macaques, and indeed these are used for vaccine development.

Depends on your credit and the bank and the card type. A low-rate credit union card can be at 7.49%. Fancy travel and rewards cards are higher, e.g. 15.99% or above. Apple Card is between 10.99% and 21.99%.

I’ve seen TRLs used in tech transfer offices and engineering departments in academia; NIH and NSF (usually associated with SBIR programs) as well as the DoE; in medical device and pharma manufacturing; and in life science VC groups. In private companies and VCs I’ve heard it used most in management and BD contexts. I think TRLs can provide a useful second axis to the more common clinical or regulatory development staging.

What TRL are you at for the original POC test, and what TRL are you at for viral detection? Any published papers for viral detection?

If one is clever, one can use SPR to interrogate a surface: monitor the surface and you can “see” the surface changing when stuff is sticking to it. If you have something with specific binding properties on that surface, like an antibody (as is used in an ELISA), with some additional effort you can maybe have an assay that detects something binding to that antibody.

I’m having difficulty understanding why SPR would be more scalable than LFAs for this type of frequent screening? And what does the ROC look like for this startup’s SPR assay?

Frankly, I don’t understand how this test is supposed to work, and I’ve used a Biacore! It might be helpful to have a technical explanation available, for domain experts to evaluate.

It’s an unfairly inflated statement even limited to the scope of SV biotech, which is only a part of the entire industry.

The US still vaccinates against polio, but we don’t use the OPV anymore: https://www.cdc.gov/vaccines/vpd/polio/index.html

The OPV is still used in the few countries where there is polio in the wild because it does have advantages over the IPV.

I mean, there’s still time for George Hotz to enter the ring and win that title.

A lament, I wish it were possible to convince tech people that they are not the only clever people in the world: regulatory bodies and medtech and pharma companies are packed with equally clever people, who are quite capable of moving fast but without breaking things, that have an unmatched advantage in having domain experience (part of which is a healthy respect/fear of the unknown in medicine, like you say, regulations are written in blood). It would be a lot more productive to support those people than to do these hackathon projects.

There is a reasonable chance that this will not be as useful as the team hopes:

1) They are increasing maximum pressure and pressure rate changes beyond the built-in design parameters. If these new parameters are outside what the engineering requirements document spec, these changes are a problem in seeking EUA.

2) In regulatory affairs, authorized, cleared, and approved have very specific (and enforceable) meanings. If someone is loose with how they use these words, it suggests they don’t have someone with regulatory experience involved (a negative sign). The earlier the team can engage with someone with regulatory experience, the better.

They are using lay terminology, but it doesn’t matter for regulatory affairs: authorization, approval, and clearance are legally distinct and companies are fined for using the wrong word.

We’re also likely to see convalescent sera available shortly, and neutralizing antibodies available in several months. Those, along with more widely available testing, will help us tread water until we develop a good drug or vaccine.

That’s a bug, not a feature: the OPV went to bivalent a few years ago to reduce the odds of vaccine-related cases.

I don’t see that any regulatory authority would approve something that is capable of spreading, regardless of the possible benefits: it would violate medical ethics. Reread the Belmont Report.

There are many teams all over the world that are looking for less deadly (and more deadly!) strains to guide development of therapies. They’re too busy right now to post on message boards or speak to reporters. It’s however extremely unlikely that a less deadly strain will become the therapy, although it could be the basis of a therapy (but I think this too is unlikely).

A naturally attenuated strain would still be regulated. In the US, 21 USC §321(g):

> (1) The term "drug" means… (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals;

CBER would be the responsible center for the FDA. Other countries have analogous regulations.

Could you come to market with a naturally attenuated strain? Yes. Would it take less time? Not really, because you don’t get to do an “end run around the regulations” as you put it in another comment. The logistics of making sure it works and then setting up the supply chain and quality systems are what take the most time. There are no shortcuts in medicine.