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Pharmaceutical executive claims FDA 'red tape' holding up Coronavirus antibodies test
Fox News ^ | 04/09/2020 | Victor Garcia

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 ...


TOPICS: Business/Economy; Culture/Society; Government; News/Current Events
KEYWORDS: antibodies; coronavirus; fda; pharmaceuticals
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1 posted on 04/09/2020 11:45:41 AM PDT by SeekAndFind
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To: SeekAndFind

The FDA being against Making America Great again?

Quelle surprise.


2 posted on 04/09/2020 11:46:57 AM PDT by Paladin2
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To: SeekAndFind

How many members of the Rat/RINO uniparty of treason have to be paid off first?


3 posted on 04/09/2020 11:48:07 AM PDT by GrandJediMasterYoda (As long as Hillary Clinton remains free equal justice under the law will never exist in the USA)
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To: SeekAndFind

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.


4 posted on 04/09/2020 11:49:50 AM PDT by iontheball
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To: SeekAndFind

Whats new


5 posted on 04/09/2020 11:49:57 AM PDT by Bell Bouy II
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To: SeekAndFind

Bookmark


6 posted on 04/09/2020 11:51:20 AM PDT by Chgogal (Wuhan Virus, Chinese Virus, Kung Fu Virus - Wuhan Chinese Kung Fu Virus aka CCP virus.)
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To: SeekAndFind

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.


7 posted on 04/09/2020 11:52:38 AM PDT by absalom01 (You should do your duty in all things. You cannot do more, and you should never wish to do less.)
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To: SeekAndFind

FDA needs to be reformed STAT.

That said, a test that isn’t valid can create havoc.


8 posted on 04/09/2020 11:52:49 AM PDT by Drango (1776 = 2020)
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To: SeekAndFind

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.


9 posted on 04/09/2020 11:53:02 AM PDT by ifinnegan (Democrats kill babies and harvest their organs to sell)
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To: iontheball

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.


The FDA is notorious not for conspiracies, but for just plain being slow, excessively pedantic, and overly officious. They are not the only driver for high US pharmaceutical costs, but they are a big one, with approval for successful new drugs costing half a billion dollars or more (and all the accompanying administrative work that implies) and taking years.


10 posted on 04/09/2020 11:57:42 AM PDT by lepton ("It is useless to attempt to reason a man out of a thing he was never reasoned into"--Jonathan Swift)
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To: ifinnegan

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.


11 posted on 04/09/2020 11:57:54 AM PDT by petitfour (APPEAL TO HEAVEN)
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To: SeekAndFind

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.


12 posted on 04/09/2020 12:04:22 PM PDT by Wuli
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To: ifinnegan

“”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.””


13 posted on 04/09/2020 12:06:33 PM PDT by aquila48
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To: SeekAndFind

FDA? Red tape? Say it ain’t so!


14 posted on 04/09/2020 12:07:04 PM PDT by Slainte (Never attribute to conspiracy that which is adequately explained by stupidity. Or arrogance.)
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To: ifinnegan

Companies that whine publicly about red tape at FDA


You’d probably be amazed at the FDA requirements placed on vendors for pharmaceutical companies for any work they do, including work that would appear to be unrelated to the testing of manufacture of drugs. I had a short job doing some off-site work for a telecom company, and had to take hours of mandated training (with tests) on the FDAs history, various standards for drug inspection (domestic and international), and the process for approving drugs. The workers on the account had to keep logs any time they touched the equipment which carried the pharmas circuits (and lots of other folks’), as well as specific software setups (including banning types of programs common for circuit and device diagnostics) on those workers’ laptops, and submit to audits.

All of this comes at a cost.

It was just unreal for an area so far removed from production or research.


15 posted on 04/09/2020 12:20:56 PM PDT by lepton ("It is useless to attempt to reason a man out of a thing he was never reasoned into"--Jonathan Swift)
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To: SeekAndFind

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.


16 posted on 04/09/2020 12:49:02 PM PDT by American in Israel (A wise man's heart directs him to the right, but the foolish mans heart directs him toward the left.)
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To: SeekAndFind

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.


17 posted on 04/09/2020 12:55:47 PM PDT by PapaBear3625 ("Those who can make you believe absurdities, can make you commit atrocities." -- Voltaire)
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To: SeekAndFind

“”””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.


18 posted on 04/09/2020 1:06:19 PM PDT by Presbyterian Reporter
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To: SeekAndFind

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 ...


19 posted on 04/09/2020 1:40:38 PM PDT by catnipman (Cat Nipman: Vote Republican in 2012 and only be called racist one more time!)
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To: SeekAndFind

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.


20 posted on 04/09/2020 2:19:43 PM PDT by momincombatboots (Ephesians 6... who you are really at war with)
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