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Step 3: Clinical Research (FDA site says trials usually take years...not months like for COVID19)
FDA ^ | January 4, 2018 | N/A

Posted on 08/09/2021 6:51:08 PM PDT by DoodleBob

...Researchers design clinical trials to answer specific research questions related to a medical product. These trials follow a specific study plan, called a protocol, that is developed by the researcher or manufacturer.

...

Phase 1

Study Participants: 20 to 100 healthy volunteers or people with the disease/condition.

Length of Study: Several months

Approximately 70% of drugs move to the next phase

Phase 2

Study Participants: Up to several hundred people with the disease/condition.

Length of Study: Several months to 2 years

Approximately 33% of drugs move to the next phase

Phase 3

Study Participants: 300 to 3,000 volunteers who have the disease or condition

Length of Study: 1 to 4 years

Approximately 25-30% of drugs move to the next phase

Phase 4

Study Participants: Several thousand volunteers who have the disease/condition


(Excerpt) Read more at fda.gov ...


TOPICS: Culture/Society; Government; News/Current Events
KEYWORDS: clinicaltrials; covid19; fda; vaccine; vaccines; warpspeed
Hmmm...that's funny..on the FDA's own site covering their "Drug Review Process", it's stated:

"It's the clinical trials that take so long--usually several years," says Sandra Kweder, M.D., deputy director of the Office of New Drugs in the CDER.

So....why in the Wide World of Sports, with a shot that uses a heretofore never-released platform (messenger RNA), is Fauci Hopeful COVID Vaccines Get Full OK by FDA Within Weeks/after about nine months of trials?

That'd be like fast-tracking autonomous navigation systems.

What could POSSIBLY go wrong?

1 posted on 08/09/2021 6:51:08 PM PDT by DoodleBob
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To: DoodleBob

Its the old adage “Fast, Cheap or Good? Pick Two.”

In this case they went for Fast and Good. Throw billions of dollars at a problem and you can solve anything quickly.


2 posted on 08/09/2021 6:56:06 PM PDT by Renfrew
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To: DoodleBob
Think Thalydomide
3 posted on 08/09/2021 7:01:21 PM PDT by blackdog (Sophisticated so public policy is not applicable. )
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To: DoodleBob

General timeline is 10-15 years


4 posted on 08/09/2021 7:02:47 PM PDT by Secret Agent Man (Gone Galt; Not Averse to Going Bronson.)
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To: DoodleBob

Sounds like we still have a few boosters to go before testing winds down later this decade.


5 posted on 08/09/2021 7:07:19 PM PDT by NWFree (Somebody has to say it)
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To: DoodleBob
I found this the other day doing some research.


6 posted on 08/09/2021 7:12:48 PM PDT by LostInBayport (When there are more people riding in the cart than there are pulling it, the cart stops moving...)
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To: DoodleBob

With the reported Adverse Effects including multiple deaths and long-term injury this trial phase would have been shut down long ago. If it is cleared by Labor Day, something is obviously WRONG! Stated by a freeper who spent his whole career in Medical Devices and mitigating FDA warning letters.


7 posted on 08/09/2021 7:19:02 PM PDT by wetgundog
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To: DoodleBob

The NIH and CDC are just garbage, politically and monetary driven. If they cared about Americans everyone should have been taking Hydroxychloroquine in an emergency type fashion before and while the vaccines were being developed and tested. Ivermectin too as I think India has done with its citizens with some good results. Instead they politicized it and let Big Pharma in on the cash cow resulting in needless deaths and significant illness for many. Exploitative pieces of garbage and pond scums unworthy of their callings.


8 posted on 08/09/2021 7:25:44 PM PDT by tflabo (Truth or tyranny )
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To: LostInBayport

That’s a very good summary.

We are lucky we had someone with business experience like Trump in charge. He could slice through the red tap and build an efficient system.

If Biden was in charge last year we would still be at the stage of experimenting on mice.


9 posted on 08/09/2021 7:33:21 PM PDT by Renfrew
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To: Renfrew

That’s one way to look at it.


10 posted on 08/09/2021 7:37:11 PM PDT by LostInBayport (When there are more people riding in the cart than there are pulling it, the cart stops moving...)
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To: Renfrew; LostInBayport
The are many reasons why sour mash isn't Jack Daniels. A big reason is fermentation which happens with the passage of time. You can't simply wave your hand and get Jack Daniels.

The same is true of clinical trials and vaccine approvals. I don't mind that these shots were made available through EUA. Some day, after years of trials, maybe they'll become fully-approved vaccines following the proper protocols.

But let's not confuse mash with Jack. These shots are mash. Maybe, some day, they can age and become Jack. But without years of trials, they'll be mash, even if someone calls them approved.

So, let's not follow the political science. This is a shot released to the public under EUA:

....and this is an approved vaccine subjected to years of clinical trials and not approved by following the political science:


11 posted on 08/09/2021 7:50:01 PM PDT by DoodleBob (Gravity's waiting period is about 9.8 m/s^2)
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To: DoodleBob

The USAF rolled out an Adenovirus vaccine in late 1973/early 1974 and used USAF recruits for the initial part of the trial while simultaneously testing the vaccine in lab animals to expedite the approval. Unfortunately the researchers found a cancer gene embedded within the vaccine’s attenuated virus that caused tumors in guinea pigs and hamsters. The USAF abruptly stopped the trial and never told the recipients of the vaccination they were part of a trial.


12 posted on 08/09/2021 7:52:20 PM PDT by vetvetdoug
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To: DoodleBob

Warp speed is something from science fiction.


13 posted on 08/09/2021 8:10:05 PM PDT by Lisbon1940 (No full-term Governors (at the time of election))
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To: DoodleBob

Everyone wanted to get back to normal and wouldn’t wait. The real question is...why pick unused platform?
I think there are few reasons.
1) it would be novel and patentable. No one is going to commit 0.5 to greater than 1 billion dollars and not have long term monetary return possibilities.
2) No benchmark to compare with...so if it works...one cannot say old school vaccine is better. Everyone knew vaccines have to be tested long time. For a novel approach ...no one knows how long to test.
3) Giving an attenuated virus could lead to infection(if attenuation did not render virus harmless)

It doesnt matter...one cannot force a medicine on anyone. Especially if it is not 100% effective...and long and short tsrm sife effects are not completely known.
Public is panicking cause it expects a succesful end to the disease..but this is no hollywood movie. Mankind may NOT always prevail. Estimated that 30 to 60 percent of europe died in the black death. I hope I am proved wrong.


14 posted on 08/09/2021 8:21:09 PM PDT by Getready (Wisdom is more valuable than gold and diamonds, and harder to find.)
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To: DoodleBob

All I can say is that one year from now you’ll see Merck start selling an anti-thrombosis drug from Ono Pharmaceuticals.


15 posted on 08/09/2021 8:54:03 PM PDT by struggle
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To: null and void; Jane Long; Grampa Dave; ransomnote

FYI


16 posted on 08/09/2021 10:47:11 PM PDT by DoodleBob (Gravity's waiting period is about 9.8 m/s^2)
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