How long does it take to pass the EUA normally?
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Posted On: 04/18/2020 8:33:31 AM
How long does it take to pass the EUA normally?
There is no normal. The FDA group that reviews EUA was established less than 3 months ago. The first thing they did was establish certain practices that have become cumbersome, such as approving almost as a rubber stamp older less accurate DNA based applications without looking at the companies offering them. This has allowed certain "rookie" companies like AYTU to get early EUA based on a flawed (some people claim counterfeit) kits, while raising the status of companies such as Roche and Abbott, both of whom had been in the virus detection business for decades, but who offer (Sean Hannity's hero worship aside) lesser applications that for the most part are over 35 years old. Likewise the FDA has basically crippled those companies with Antibody based methods, holding their kits off the market for over 2+ months because someone at the FDA thinks they are not accurate enough. So the Antibody kits so loved by our poster, the self-claimed expert, Always, are now in drip, drip approval mode.
However, if you want to read all of the knowledge in the world about EUA, go to the iHub board. There are about 100 stock traders, day traders and flips masquerading as experts over there. People even masquerading as former FDA people. Over there you will find what you are looking for. Over here you'll find good questions, but also a few people masquerading as experts too, but for the most part this board is more civilized and there is no real hatred toward the CEO. Right Always?
There is no normal. The FDA group that reviews EUA was established less than 3 months ago. The first thing they did was establish certain practices that have become cumbersome, such as approving almost as a rubber stamp older less accurate DNA based applications without looking at the companies offering them. This has allowed certain "rookie" companies like AYTU to get early EUA based on a flawed (some people claim counterfeit) kits, while raising the status of companies such as Roche and Abbott, both of whom had been in the virus detection business for decades, but who offer (Sean Hannity's hero worship aside) lesser applications that for the most part are over 35 years old. Likewise the FDA has basically crippled those companies with Antibody based methods, holding their kits off the market for over 2+ months because someone at the FDA thinks they are not accurate enough. So the Antibody kits so loved by our poster, the self-claimed expert, Always, are now in drip, drip approval mode.
However, if you want to read all of the knowledge in the world about EUA, go to the iHub board. There are about 100 stock traders, day traders and flips masquerading as experts over there. People even masquerading as former FDA people. Over there you will find what you are looking for. Over here you'll find good questions, but also a few people masquerading as experts too, but for the most part this board is more civilized and there is no real hatred toward the CEO. Right Always?
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