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-> Coronavirus Health Questions
amother
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Wed, Jul 05 2023, 5:48 pm
ChossidMom wrote: | Wow. Neverveven thought of that.
But who ever thought of any of this whacko stuff that sci fi movies are made of! |
It’s crazy. You don’t wanna know how many people have access to your dna or fingerprints. And if you ever downloaded weibo or temu apps or anything else from China, they have access to everything in your phone.
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ChossidMom
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Thu, Jul 06 2023, 5:18 am
mRNA COVID Shots Are Undoubtedly Gene Therapy Products
But the regulatory agencies didn’t define them as such to bypass stringent safety standards.
Now, manufacturers are exploiting the lack of oversight to replace classic vaccines with more mRNA shots.
Article: https://www.theepochtimes.com/.....lantf
Now that the pandemic has ended, researchers are urging regulatory agencies to consider the safety issues associated with the rapid approval of COVID-19 vaccines—and to correctly classify messenger RNA (mRNA) vaccines as gene therapy products (GTPs) to prevent pharmaceutical companies from bypassing regulatory standards.
According to a paper published in the International Journal of Molecular Sciences on June 22, COVID-19 mRNA vaccines, by mode and action, are gene therapy products and should adhere to different regulatory standards. Yet U.S. and European regulatory agencies have not classified COVID-19 mRNA vaccines as gene therapy products, which has allowed them to be regulated as vaccines against infectious diseases instead of being subjected to the more stringent regulation of GTPs.
Because current regulatory guidelines either do not apply, do not mention RNA therapeutics, or do not have a widely accepted definition for these products, regulatory agencies adopted a modified and accelerated approval process for COVID-19 vaccines in the form of a “rolling review.”
A rolling review is a regulatory tool typically used during a public health emergency to speed up the assessment of data for medicines or vaccines. It allows data to be reviewed as it becomes available—without the complete data package or specific controls.
This process led to broad and continuous biodistribution of mRNA COVID-19 vaccines that were not thoroughly studied and yielded tests with noncompliant results regarding purity, quality, and batch homogeneity. Manufacturers are now planning to replace classic vaccines with mRNA vaccines using the same process—starting with influenza vaccines.
Vaccines With mRNA Technology Are Gene Therapies
The Centers for Disease Control and Prevention currently defines a “vaccine” as a preparation used to stimulate the body’s immune response against diseases. However, the agency’s definition was changed in 2021 out of concern it didn’t apply to COVID-19 vaccines.
A vaccine must contain an antigen to trigger the body’s natural immune response. Pfizer and Moderna’s mRNA vaccines do not contain antigens. The active substance used to elicit an immune response in these vaccines is the mRNA—a form of nucleic acid and the genetic material of the SARS-CoV-2 virus that provides instructions to the body for producing antigens—spike proteins.
In other words, the mRNA is not the substance causing active immunization. Instead, the mRNA must be translated into protein by the cells of the person vaccinated, and that person’s immune system must produce its own antigens to trigger an immune response.
The U.S. Food and Drug Administration (FDA) states that gene therapy seeks to “modify or manipulate the expression of a gene or to alter the biological properties of living cells for therapeutic use.” Moderna’s Q2 2020 filing with the Securities and Exchange Commission acknowledged that mRNA is “considered a gene therapy product by the FDA.” In addition, BioNTech founder Ugur Sahin, in a 2014 article stated, “One would expect the classification of an mRNA drug to be a biologic, gene therapy, or somatic cell therapy.”
According to the FDA, mRNA vaccines are comparable to the TypeIA of prodrugs—substances that, after administration, are converted in the body into pharmacologically active drugs.
This “prodrug property” could suggest that additional controls should be applied in addition to those required for vaccines. However, neither the FDA nor the European Medicines Agency (EMA) have referenced these qualifications for mRNA COVID-19 vaccines.
“With a conventional vaccine, you have the antigen, and you inject it into a person, and that is the thing that your immune system looks at and says, ‘ah ha,’ we need to make antibodies, T-cells, and other immune system components to what’s being injected,” said Dr. David Wiseman, a research scientist with a background in pharmacy, pharmacology, and experimental pathology, in an interview with The Epoch Times.
“The prime reaction of an mRNA vaccine is that it instructs the body how to make the antigen of interest. So, it’s similar to a prodrug, which is converted inside the body via metabolism and enzymes into the desired drug effect. The substance you’re injecting isn’t doing the final action; it leads to the thing that does the final action. With a prodrug, the molecule you inject does not get changed into the final molecule of the antigen, it simply provides instructions because it’s gene therapy.”
Wiseman said the FDA and EMA guidance and regulations that discuss gene therapy all define gene therapies “more or less” the same way. However, a number of years ago, the FDA decided to exclude vaccines for infectious diseases from its various guidance for unknown reasons, including vaccines made from gene therapy technology. Vaccines, in essence, were given their “own set of rules.”
However, the FDA can “change or exclude whatever they want from regulatory guidance, but it doesn’t change the biologic definition of the product,” said Wiseman. “Since Pfizer and Moderna COVID-19 vaccines meet the definition of gene therapy, they should be handled according to gene therapy guidelines.”
mRNA COVID-19 Vaccines Bypassed Essential Studies
According to the paper, because mRNA COVID-19 vaccines were not classified as gene therapy, necessary tests required for GTPs were not performed for the following:
Genotoxicity.
Genome integration.
Germ-line transmission.
Insertional mutagenesis.
Tumorigenicity.
Embryo/fetal and perinatal toxicity.
Long-term expression.
Repeated toxicity.
Excretion in the environment, such as shedding through seminal fluid or breast milk.
“The long-term safety monitoring of GTPs is required over several years whereas, for vaccines, it is generally only carried out over a few weeks,” wrote Dr. Helene Banoun with the French Institute of Health and Medical Research in the paper. “This should not be acceptable, given the persistence of the drug product and the expressed protein.”
In addition, known results of anti-cancer therapies that use gene therapy technology and mRNA vaccines could lead us to anticipate safety and efficacy problems, she added.
In the EU, gene therapy medicinal products are required to undergo “tests or trials to evaluate the risk of genome integration and germ-line transmission, even if this integration is unlikely,” and tests and clinical trials to evaluate the risk of “insertional mutagenesis, tumorigenicity, embryo/fetal and perinatal toxicity, and long-term expression.”
EMA requires “extensive studies on both the nucleic acid and the vector particle/delivery system that includes biodistribution, dose study, potential target toxicity, the identification of the target organ to obtain biological activity, toxicity linked to the expression of structurally altered proteins.”
It is necessary to insist pharmacokinetic studies be performed to determine how the body interacts with the administered substance during the entire duration of exposure—even though they are generally not required for vaccines unless there’s a new formulation or a vaccine contains novel adjuvants or excipients (inactive substances such as preservatives).
For GTPs, shedding studies are also needed to determine excretion and dissemination in the body, and biodistribution studies are needed to assess where injected compounds—such as lipid nanoparticles, the delivery system used to deliver mRNA—travel in the body and which tissues or organs they accumulate in.
After assessing Pfizer and Moderna’s COVID-19 vaccine documents obtained by attorney Aaron Siri through the Freedom of Information Act, Wiseman noted many studies listed in nonclinical summaries that should have been performed but were not.
“Several studies should have been done but weren’t done because they fell under the auspices of vaccines. But if you read the guidelines, it doesn’t say these studies are unnecessary, just that circumstances may deem them unnecessary,” Wiseman said. “We need laws for products that say you can’t just exclude them from regulations because you feel like it—because they are still gene therapies,” he said.”We are hijacking the machines of our bodies to produce spike proteins in an uncontrolled, undefined way—there are too many things we don’t know about.”
Megan Redshaw is an attorney and investigative journalist with a background in political science. She is also a traditional naturopath with additional certifications in nutrition and exercise science.
Last edited by ChossidMom on Thu, Jul 06 2023, 6:27 am; edited 1 time in total
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amother
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Thu, Jul 06 2023, 5:48 am
ChossidMom wrote: | mRNA COVID Shots Are Undoubtedly Gene Therapy Products
But the regulatory agencies didn’t define them as such to bypass stringent safety standards.
Now, manufacturers are exploiting the lack of oversight to replace classic vaccines with more mRNA shots.
Article: https://www.theepochtimes.com/.....lantf |
Nope.
From https://www.genomicseducation......ies/:
Why mRNA vaccines aren’t gene therapies
We bust another Covid-19 myth – this time about how mRNA vaccines work – in our latest blog post
11th June 2021
/in Core concepts /Tags: Covid-19, Gene therapy, Infectious disease, Technologies/
As people in the UK continue to receive Covid-19 vaccines, the subject of how and why they work is being widely discussed online. Some people are promoting the idea that RNA-based vaccines – including the UK-approved Pfizer-BioNTech and Moderna vaccines – are a form of gene therapy, but this isn’t accurate.
Read on as we break down the science to find the truth behind the myth.
RNA: a closer look
RNA is closely related to DNA and performs different but equally important functions. While our genetic information is stored as DNA in the cell nucleus, RNA acts as an intermediary, allowing the genes to be expressed.
When a gene is expressed, it is copied into RNA. This is known as a messenger RNA (mRNA) – the type used in the Pfizer and Moderna vaccines. The mRNA travels out of the cell nucleus to be used as a template to make a protein. Once the protein is made, the mRNA gets broken down.
So how do mRNA vaccines work, exactly?
How the vaccines work
All of the Covid-19 vaccines approved in the UK work by presenting a single protein that appears on the surface of the SARS-CoV-2 virus – known as the ‘spike protein’ – to the body’s immune system.
This allows the body to develop antibodies against the protein, so that if the body encounters the same protein again (notably, when a person is infected with the virus), then the immune system can react much more quickly. This process mimics the way our bodies react to many infections that we would encounter naturally.
Although all of the vaccines work by exploiting the spike protein, the way they do so is different.
The Oxford-AstraZeneca vaccine is a type of vaccine called a viral vector. It works by using a harmless virus that has been altered to have the SARS-CoV-2 protein on its surface.
The Pfizer-BioNTech and Moderna mRNA vaccines use a different approach. Instead of the vaccine containing the protein itself, it contains instructions about how to make the protein, so that the cells in our bodies can manufacture it.
The mRNA is packaged in a capsule called a lipid nanoparticle, which acts as a delivery vehicle to allow the mRNA to safely enter the cells in the body. From there, the mRNA is treated the same as any other – it is used by the cells as a template to build the protein and is then broken down. After the spike protein is manufactured by the vaccinated cell, it causes an immune response in the same way as traditional vaccines.
As mRNAs are broken down by the cell after they have been used, the RNA from the vaccine does not persist in cells. It is helpful to think of the mRNA vaccine has being a one-time set of instructions that the body then ‘forgets’, and this is very different to how gene therapies work.
Gene therapies vs mRNA therapies
Gene therapies involve making deliberate changes to a patient’s DNA in order to cure or alleviate a genetic condition. This can be by adding a functional copy of a gene, disabling a gene that makes a faulty product or changing gene activation.
The mRNA from the vaccines does not enter the cell nucleus or interact with the DNA at all, so it does not constitute gene therapy.
Gene therapies can have long-lasting effects because they permanently change the cell’s DNA, with these changes being inherited by any daughter cells that result if the cell divides. In contrast, mRNAs are always transitory and are not inherited by daughter cells, making them ideal for use in vaccines.
Although mRNA therapies have been the subject of clinical trials for many years, their role in the fight against Covid-19 has only accelerated interest in their usefulness to combat other conditions, including rare diseases and cancer.
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ChossidMom
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Tue, Jul 11 2023, 4:00 am
FYI
Every single day (every single day) I read about one or two deaths of people, every age, in Israel from "Sudden Death" (דום לב)
Every single day.
There are also daily posts online about young people who died from "turbo cancer", meaning a matter of weeks or months from when they were diagnosed.
This is today's.
A 26 year old woman died one year after her wedding. She had been perfectly healthy.
My husband's first cousin died from turbo cancer. The family was in complete shock.
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ChossidMom
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Tue, Jul 11 2023, 4:56 am
Couldn't say. And the Ministry of Health isn't telling.
I am just pointing out that the number of deaths (and excess deaths) are higher than ever. Young deaths. I certainly don't know what they are from but NOONE in an official position is asking this question. Not here in Israel and not in the U.S. The highest cause of death in Canada now is "Unexplained death".
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amother
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Tue, Jul 11 2023, 5:21 am
When there are “sudden deaths” it means either drug overdose or vaping death or suicide. Sometimes the person had a condition but it wasn’t being shared. Usually it’s an overdose or suicide.
And remember, the world is a much smaller place. You can call someone thousands of miles away and get instantaneous information. 40, 50, 60 years ago you’d find out days weeks months years later.
Just like it could be vaccines it could be from drinking water or breathing air. Or a blood clot. Or a million other things. No need to be an alarmist. HaShem has a plan.
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amother
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Tue, Jul 11 2023, 6:17 am
It's not necessarily the vaccine but it's definitely a new reality since Covid. There's an unprecedented number of people dying suddenly and many many people with new sudden medical issues.
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amother
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Tue, Jul 11 2023, 6:17 am
But I wonder, Chossidmom, what do you actually propose we do to stop this terrifying trend?
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#BestBubby
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Tue, Jul 11 2023, 6:21 am
Stop trusting medical establishment which is controlled by government and pharmaceutical companies.
Do your own research
If something is dangerous, just say No even if it means losing your job.
If enough people would refuse to obey illegal orders the government would back down. It's when the majority cave that tyranny wins.
Even those who want vaccines should stand up for medical freedom, my body, my choice.
Either we all have freedom, or nobody has freedom.
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ChossidMom
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Tue, Jul 11 2023, 7:21 am
amother Pansy wrote: | When there are “sudden deaths” it means either drug overdose or vaping death or suicide. Sometimes the person had a condition but it wasn’t being shared. Usually it’s an overdose or suicide.
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I don't know where you came up with that from. Nowadays, sudden deaths are most certainly not suicides. I don't know what planet you live on but from what I see in the Israeli press and on social media is that every single day there is a sudden death of a fairly young person.
This woman I posted about did not commit suicide. She didn't feel well, went to the hospital and died. People are being found dead in their apartments, in parks, in parked cars etc. etc. It certainly is a frightening trend And, yes, we all must remember that Hashem is running the world. But it would be prudent to TAKE NOTICE of this new trend. Once we notice and stop explaining it away as coincidence, bad pollution, lockdowns etc. - only then can we actually think about it and decide on a plan of action.
What plan of action? I don't know.
What I did is firstly, look into the whole childhood vaccine story. And I found that noone EVER tested the safety of these injections, 70 or so doses of which are given to every child in the U.S. (and probably Israel). My conclusion - never let anyone inject me or my children again with untested vaccines. Unfortunately, my kids got the whole schedule but I am now educating them as to the dangers and I hope they will be "educated consumers" and be alot more careful with their kids than I was with mine.
Here is a 30 minute presentation by Edward Dowd who used to work for the giant corporation Blackrock (that owns like half the world). Ed Dowd is an analyst and is an expert at pattern recognition. He maintains that fraud occurred in the clinical trials of the Covid vaccines and that the results of this can be seen in excess mortality and disability in the U.S.
There is a database about labor statistics - monthly employment report, which asks people questions including "Are you disabled". These questionairres are not tied to any claim. The number hovered around 29 million disabled folks till 2021.
Then, it increased to 36.1 million disabled people. As of May 2022 there is a 10% incease. If this was a stock it would be considered a trend and he would buy this stock!
The data is pure and shows that disabilities are on the rise.
There is also a HUGE increase in excess mortality in the second half of 2021, probably because of vax mandates. The people who died were young working professionals who had joined special group life policies.
In January 2022 One America's CEO said they saw a 40% rise in excess mortality!!!!! That is a one in 200 year deviation.
Here is the clip to watch Ed Dowd. (I'm sure that if you would rather stick with "suicide, vaping and drug overdoses you won't bother to watch). The numbers don't lie.
https://rumble.com/v1aui9z-edw......html
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amother
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Tue, Jul 11 2023, 7:33 am
That’s not why I’m not watching what he has to say. He works in finance, not medicine. Just like I wouldn’t ask a lawyer to rotate the tires on my car, I don’t ask or take medical advice from someone who isn’t in the medical field.
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ChossidMom
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Tue, Jul 11 2023, 7:50 am
amother Pansy wrote: | That’s not why I’m not watching what he has to say. He works in finance, not medicine. Just like I wouldn’t ask a lawyer to rotate the tires on my car, I don’t ask or take medical advice from someone who isn’t in the medical field. |
Ed Dowd is NOT a medical person. He is a numbers and data person.
He is giving you the numbers and the data.
You come to your own understanding and conclusions.
If you want medical advice I can bring you plenty of (used to be) mainstream doctors who are experts in their fields, who will tell you about the terrible devastation that the covid vaccines caused.
Here is an interview with Dr. Pierre Kory about the War on Ivermectin:
https://rumble.com/v2x8ic6-the......html
And while we're at it, here is Dr. Kory on "Uncomfortable Facts about Childhood Vaccines"
https://rumble.com/v2y4yai-dr.......html
Here is Professor Harvey Risch from Harvard (frum guy) speaking about the suppression of adverse events from the mRNA vaccines :
https://rumble.com/v1wpgms-mrn......html
Here is Dr. Peter McCullough (Cardiologist and widely published doctor) speaking about how "74% of Autopsy death were caused by the vaccines".
https://rumble.com/v2z52xi-74-......html
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#BestBubby
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Tue, Jul 11 2023, 7:53 am
You don't realize that people in the medical field don't have freedom of speech.
A doctor who criticizes vaccines can lose his license.
Even saying " there are only 2 genders" or
" a man cannot get pregnant"
Can lose your medical license.
So how can you trust those who are forbidden to tell you their REAL opinions and must toe the government line?
We are living similar to soviet union where doctors and scientists had to parrot socialist propaganda.
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ChossidMom
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Tue, Jul 11 2023, 8:02 am
#BestBubby wrote: | You don't realize that people in the medical field don't have freedom of speech.
A doctor who criticizes vaccines can lose his license.
Even saying " there are only 2 genders" or
" a man cannot get pregnant"
Can lose your medical license.
So how can you trust those who are forbidden to tell you their REAL opinions and must toe the government line?
We are living similar to soviet union where doctors and scientists had to parrot socialist propaganda. |
How dare you say a man cannot get pregnant!!! What are you - a biologist?
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amother
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Tue, Jul 11 2023, 8:07 am
ChossidMom wrote: | Ed Dowd is NOT a medical person. He is a numbers and data person.
He is giving you the numbers and the data.
You come to your own understanding and conclusions.
If you want medical advice I can bring you plenty of (used to be) mainstream doctors who are experts in their fields, who will tell you about the terrible devastation that the covid vaccines caused.
Here is an interview with Dr. Pierre Kory about the War on Ivermectin:
https://rumble.com/v2x8ic6-the......html
And while we're at it, here is Dr. Kory on "Uncomfortable Facts about Childhood Vaccines"
https://rumble.com/v2y4yai-dr.......html
Here is Professor Harvey Risch from Harvard (frum guy) speaking about the suppression of adverse events from the mRNA vaccines :
https://rumble.com/v1wpgms-mrn......html
Here is Dr. Peter McCullough (Cardiologist and widely published doctor) speaking about how "74% of Autopsy death were caused by the vaccines".
https://rumble.com/v2z52xi-74-......html |
Dr. Kory isn’t a mainstream doctor. His papers have been retracted and he contradicts himself.
Professor Risch isn’t at Harvard. He’s at Yale. And Yale has come out with a statement that says he’s an oncologist, not an infectious disease specialist. https://medium.com/@gregggonsa.....7b2b0
Dr. McCullough is another conspiracy theorist who also contradicted himself. He also said very dangerous things, like someone who got covid can’t get it again. He also said that he’s justified in compromising medical research.
I can go into each article and explain how they twist their words, but I don’t have time right now.
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ChossidMom
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Tue, Jul 11 2023, 10:14 am
Calling people "conspiracy theorist" is what the media and the mainstream crooks do in order to discredit them when they do not know how or can't talk about the issues.
Saying you don't have time to do it is another way.
I wonder what you have to gain by trying to discredit these doctors.
Does it make you feel you can sleep better at night knowing that you may have harmed yourself? I just don't get it.
Why can't you let that crazy Chossidmom spew her "conspiracy theories" and IGNORE?
Sorry, I said Harvard and not Yale.
Professor Risch is an EPIDIMIOLOGIST.
Dr. Harvey Risch is Professor Emeritus of Epidemiology at Yale. He provided testimony to the US Senate regarding the COVID-19 pandemic and has spoken widely about his opposition to masking, vaccine mandates, and the reliability of PCR tests – along with his research on COVID prevention and treatment with existing drugs.
Dr. Harvey Risch fought vaccine mandates for city workers in New York, saying that those who have recovered from COVID-19 are better protected by natural immunity. Despite his long history of work in epidemiology, Dr. Risch's statements about alternative COVID treatments were criticized by his peers, who wrote an open letter in August 2020 signed by 24 doctors at the Yale School of Public Health. But Dr. Risch has continued voicing his concerns about masking, mandates, and the ever-growing list of COVID-19 variants – and government missteps that he believes have worsened the pandemic.
Find Dr. Harvey Risch on Telegram at https://t.me/HarveyRischMDPhD
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ChossidMom
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Tue, Jul 11 2023, 10:16 am
And here's a little something about Covid Propaganda and Censorship with Dr. Pierre Kory.
https://rumble.com/v2bp8xi-dr.......html
He explains about the war on repurposed drugs and how it's all about the bottom line of the pharmaceutical companies.
Watch it and open your mind a bit. Learn about DISinformation.
Last edited by ChossidMom on Tue, Jul 11 2023, 10:22 am; edited 1 time in total
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