Posted on 04/09/2020 11:45:41 AM PDT by SeekAndFind
Dr. Stephen McColgan, chief medical officer at California-based Vivera Pharmaceuticals, told "Tucker Carlson Tonight" Wednesday that his company's rapid coronavirus antibody test is ready to be deployed, but is being held up by "red tape" at the Food and Drug Administration (FDA).
"We have a rapid antibody test. And the key to this is, this is part of the solution to the crisis," McColgan said. "It identifies patients that have immunity and it identifies people that can give plasma [to] critically ill patients.
"It was developed in Germany," McColgan said. "Germany has the lowest mortality from COVID-19 globally at this point, and they've tested everybody. So this is good. It's used by our allies in Europe."
McColgan described the test as "high-quality" and "high-value," adding that its deployment is part of his company's goal to "get America back to work again and to make America well again."
"When you have a patient that does have the infection [and] recovered, they have the antibodies, the antibodies mean they have immunity," McColgan said. "So when you spin off the plasma on their blood and give it to the critically ill patient, then those antibodies fight the viral infection and allow that patient to recover ... So it's critical."
McColgan said his company has had the test ready for three weeks and was "trying to deploy it."
"You know, the red tape in the FDA and President Trump has been trying to cut through it," he said. "I don't know why New York's been crying about, you know, no testing, no tests ... You know, it's always sort of the red tape of government moves slowly."
(Excerpt) Read more at foxnews.com ...
The FDA being against Making America Great again?
Quelle surprise.
How many members of the Rat/RINO uniparty of treason have to be paid off first?
More stalling. Why? Could it be they do not want to know when and to what extent Americans have COVID-19 anti-bodies? If I have ant-bodies, I would have acquired them at the end of December when I had a vicious back to back virus attack.
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It seems that Trump has to personally intervene in every single case to get the FDA to do its job. There’s only so much one man can do.
Time to clean house at the FDA, that’s for sure.
FDA needs to be reformed STAT.
That said, a test that isn’t valid can create havoc.
Blah blah blah.
When you hear all these stories about China giving millions of test kits to Europe etc...those kits are worthless because their results are highly unreliable.
The US is leader in the world because it is stringent in qualification and validation.
Companies that whine publicly about red tape at FDA are usually incompetent and don’t know how to address legitimate questions and comments from the FDA or worse, their tech isn’t working.
More stalling. Why? Could it be they do not want to know when and to what extent Americans have COVID-19 anti-bodies? If I have ant-bodies, I would have acquired them at the end of December when I had a vicious back to back virus attack.
Are you talking about the companies President Trump touted in his first big Coronavirus meeting? The companies who couldn’t get their test kits out there due to the FDA and CDC? Maybe I have the story wrong.
We need a Federal law that commands that during a national emergency all Federal agencies are commanded to get out of the way when private solutions are offered for things they are not doing and cannot themselves do.
“”It was developed in Germany,” McColgan said. “Germany has the lowest mortality from COVID-19 globally at this point, and they’ve tested everybody. So this is good. It’s used by our allies in Europe.””
FDA? Red tape? Say it ain’t so!
Companies that whine publicly about red tape at FDA
All of this comes at a cost.
It was just unreal for an area so far removed from production or research.
Socialism and Central planning Sucks. Even the American brand Sucks. Only difference is we should be smarter than that.
FDA needs a drastic Budget cut.
Because the con is over if widespread antibody tests show that most people have already gotten it, had a mild or no reaction, and are now immune.
“”””It was developed in Germany,” McColgan said. “Germany has the lowest mortality from COVID-19 globally”””
WAPO mentioned Germany was using the antibody test, but they excluded the fact that Germany has a much lower mortality rate than the USA and other European countries.
well, there’s red tape and then there’s a legitimate requirement to prove whether a test works, that is, has it been tested enough times on the enough of the right kind of people to demonstrate the degree of false negatives and false positives based on sensitivity and specificity ... If those two numbers or either unknown or known but way too large, then the test is useless ...
We are searching for a trustworthy lab diagnostic kit as well. As master laboratorians just any fly by the night producer wont work. But it is an easy sell to suckers who don’understand rlthe complexities of immunity, but are just putting a test out there for cash money.
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