IdoRA

14 ms·

61.
by IdoRA 6y ago
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
62.
by IdoRA 6y ago
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 individual
63.
by IdoRA 6y ago
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 i
64.
by IdoRA 6y ago
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%.
65.
by IdoRA 6y ago
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 pri
66.
by IdoRA 6y ago
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?
67.
by IdoRA 6y ago
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 (a
68.
by IdoRA 6y ago
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, a
69.
by IdoRA 6y ago
It’s an unfairly inflated statement even limited to the scope of SV biotech, which is only a part of the entire industry.
70.
by IdoRA 6y ago
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 i
71.
by IdoRA 6y ago
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 compa
72.
by IdoRA 6y ago
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 engineeri
73.
by IdoRA 6y ago
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.
74.
by IdoRA 7y ago
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.
75.
by IdoRA 7y ago
That’s a bug, not a feature: the OPV went to bivalent a few years ago to reduce the odds of vaccine-related cases.
76.
by IdoRA 7y ago
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 a
77.
by IdoRA 7y ago
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 oth