Master class in pharmaceutical regulations: the difference between EAU and EUA that nobody on Earth has noticed in the past 3 years. Including me until yesterday afternoon.
If the various efforts to work through the system fail, and I think they will fail, it seems appropriate to try to work through the system to change the system. But I have watched for over 30 years the system defend itself against all efforts to reform the system. Graham Rudman Hollings and the shutdown under Newt Gingrich and the efforts of Ross Perot to build a reform party are a couple of examples. There are dozens more.
The system is very profitable the way it is. So there is enormously powerful resistance to changes that would reduce those profits. It's a parasite. These are hard to remove.
At the start of the shots, I was worried that they would create a mild shot with minimal issues and first get approval and get put on the childhood schedule, so as to enjoy the immunity protection under the 1986 fascist act (which Senator Kennedy pushed along with other sellout cowards).
They also were planning to give the covid shots the same ridiculous ability to change the shots but not need to be retested, as the shitty flu shots. This was done early to plan it out.
The next step, I felt that pharma would turn up the dial on the shots but sit and rely on the approval as safety. Nope, despite all of this regulatory planning err scamming, the lazy aholes decided to ride the PREP act forever and not even make the "approved" shot, corninarty/spikevax/etc.
I'm also surprised that despite being able to rig studies to make deadly drugs like vioxx look safe, even with "demonstration" purpose, they handed a study that shows clear issues to the FDA for approval. The FDA went and rubber stamped it.
So, instead of Pfizer getting the blame, they can easily point the finger at the FDA etc and say, look we gave them muddy safety results and they decided it was safe, not us! That also explains why it was not advertised by pharma but the media and the corrupt idiot agencies. Both the media and the agencies are the truly guilty ones if this had a chance of facing a case.
Pfizer, etc handed them a piece of shit trial on purpose, instead of faking it as truly safe!
Debunk bro, JJ Couey, and Kevin all suffer from what you wisely described before:
"The evolutionary psychologist William von Hippel found that humans use large parts of thinking power to navigate social world rather than perform independent analysis and decision making. For most people it is the mechanism that, in case of doubt, will prevent one from thinking what is right if, in return, it endangers one’s social status. This phenomenon occurs more strongly the higher a person’s social status. Another factor is that the more educated and more theoretically intelligent a person is, the more their brain is adept at selling them the biggest nonsense as a reasonable idea, as long as it elevates their social status. The upper educated class tends to be more inclined than ordinary people to chase some intellectual boondoggle. "
Even after carefully reading this article, it's hard to understand the various legal distinctions. A conspiracist would say this was deliberate ;)
I guess the first thing to know is that even by the FDA, EAU and EUA are sometimes used interchangeably. This makes it hard to tell which category applies. For example, the last slide mentions IND as one of the steps leading to an eventual EUA. By which they really mean EAU?
And it is rather shocking that they have large scale manufacturing coincident with the first step of safety testing, as your yellow box points out. Imagine that the safety testing ended up showing the stuff was very unsafe. But in the meantime they've invested in a lot of large scale manufacturing. If you were a pharmaceutical company and a government that was overseeing all this, what would your reaction be, hmmm? Start over, or sweep the whole thing under the rug? Answer is left to the reader's imagination.
The craziest part about this whole pandemic, mass poisoning is it is in the open, and it just continues. The evidence is ignored, this in itself tells us the system has collapsed. It is not time to fix it but start over. I need to provide some context of our present state of awareness of this issue. I was in large office type meeting yesterday where several comments were made about getting more flu and covid shots. We should not think we are close to a breakthrough of awareness of the masses, it didn't sound like that to me.
Excellent article, Sasha. I’ve arrived at this conclusion: the only thing we can do is simply refuse all these injections, as well as all the prescription drugs foisted upon the population under the false idea that they’ll make people ‘healthier’. They do exactly the opposite, of course…they kill people in slow motion; it’s right there before our eyes in plain sight. in other words, eliminate their customer base. I can’t think of what else to do, as their motivation is all about greed for more $ and control/power. Of course, then they just invent new drugs (absolutely not medicine)to sell…but then I wish folks would refuse all of those, too. It’s breathtaking (and not in a good way) how successful the brainwashing propaganda has been, on so many people. It’s so frustrating.
Hmm? Though I don’t understand the science, the gist of it does make me wonder how much the Smith-Mundt Act has to do with the lies and deceit? Where the original 1948 Act prohibited the “reporting” of government-authorized propaganda on U.S. citizens, Obama’s modernized 2012 version lifted that prohibition.
The laws that they have written are so confusing and complex that no one can really truly understand them, even if they are working tirelessly to do so. They are essentially a free ticket for really *smart* criminals to do whatever they want. This bureaucratic criminal legal web seems to have permeated all sectors of government, which government is clearly in bed with large corporations. I doubt we can fix it without burning down the system. Society just always seems to have psychopaths that rise to the top.
What is the answer? The founding fathers tried to prevent it by delegating most powers to the states but that was undermined over a century ago. We are right where we should never have been if it hadn’t been for the “emergency” of war and the need to start federal taxation. Most Americans are too ignorant to want to go back to the original intent of the constitution so we just continue barreling down the same path. More money siphoned off the public and put into the hands of those who should least have it. Eugenicists. War mongers. Pharma. Bankers.
I’m not aware of any other Covid skeptic who has asked this question: WHY would it be so important to push the start date of virus spread back several months? In this speculative deep dive, I identified several possible answers to this question.
One of my answers/explanations: The producers of this faux pandemic HAD to have all these excess deaths. The most important parts of the program couldn't commence until the excess deaths happened.
Usually, I point people to the Brook Jackson case, but it is hard for many people to parse the legalese or grasp the argument of the pfizer attorneys. Similarly, although the phrase "shall not constitute a clinical trial" starkly refutes the idea that these were tested for safety or efficacy, it is hard for people to directly grasp the implications of that language. Frankly, it is hard to believe they could even write something so sinister into law but there it is.
This VRBPAC quote is on a whole different level! A guy named DR FINK of all things outlining how great EUA is because they can do whatever they want with no standards!! No informed consent! No regulations!
I sincerely hope that quote will feature prominently in many future criminal trials.
> The mRNA is poison with or without SV40, because it is transfecting cells and nothing positive to health can happen that way. Only damage can result from this.
That last bullet I 100% agree with, and I don’t believe Kevin McKernan or anyone involved in the vial testing activities disagrees with it either.
> That is not to diminish the point that even in the “uncontaminated” form, the mRNA platform is a very dangerous poison and should not be used for any application.
Reply: Thank you Sasha for all you and many others do. JJ Couey's point that the platform is just bad fails to get much traction.
I too am glad and follow intently Kevin Mckernan's substack. I follow many like your self who point out the flaws in this whole process. Katherine Watt and yourself make courageous arguments.
I am not new to this madness. My parents in 1963 leased 200 acres to grow the family beef, milk and eggs without hormones or antibiotics. My parents then were enraged and profoundly concerned that this could happen.
In 1970 I completely exited the corporate food systems. Began growing my own and purchasing what my wife and I didn't grow from local organic/regenerative growers in our area. That commitment has only deepened with the passing years.
In the 1960s and 1970s there was a popular awareness of the hijacking of the food supply. But the need to survive in a corporate culture overwhelmed the movement and "going along to get along" became a way of life.
Now with C-19 people are startled into awareness and wonder how this happened and what can be done. A lot needs to be done. It happened because most citizens went to sleep in the USA.
It will take a lot of work to roll this back. I have doubts that RFKjr, Trump, Vivek Ramaswamy, Biden, or Biden substitute Gov Newsom have the stones to lead a movement to roll this back.
My wife and I worked diligently on Prop 37 to LABLE GMOS in Californina. It was a grass roots movement with very little money and started by an amazing women Pam Leary. But all Corporate Food and AgriBiz had to do to win is spend lots of money in the last few weeks before voting (Second Tues of Nov) and broadcast half truths to prevail.
There are ways forward. They take energetic vigilance, life style changes and absolute support for local organic gardeners and farmers. These changes in our life as citizens of the Earth enhance our immune system, make peace with Climate Change (a bit of a farce, it is really corporate pollution). More can be done that can be outline in other posts.
Well done. Thank you. People have a hard time accepting the legal framework that all counter-measures require are declarations and approvals. No trials, no testing, no quality control and no informed consent. It should not have been possible. Courts might still rule that Geneva conventions and Nuremberg principles still apply despite the legal attempts to circumvent them.
Magnificent in its simplicity, and remarkably well articulated so much so that a layperson can comprehend; and likewise empathize with the horror of it all: 7 in my small town died suddenly since 2021 , others with blood cancers, sudden massive blood clots. The pshychosis of silence is maddening. We all know but dare not say. Maybe someday Sasha you can put togehter a glossary of these acronymns as those used in this paper. I have done so for myself, but your doing would give greater understanding and proper definitions. I wish you would also get invited to the Highwire. I also think a book is in order.
Do C-19 Vax Manufacturers Violate cGxP?
If the various efforts to work through the system fail, and I think they will fail, it seems appropriate to try to work through the system to change the system. But I have watched for over 30 years the system defend itself against all efforts to reform the system. Graham Rudman Hollings and the shutdown under Newt Gingrich and the efforts of Ross Perot to build a reform party are a couple of examples. There are dozens more.
The system is very profitable the way it is. So there is enormously powerful resistance to changes that would reduce those profits. It's a parasite. These are hard to remove.
Ceteram censeo fda et cdc delenda est.
At the start of the shots, I was worried that they would create a mild shot with minimal issues and first get approval and get put on the childhood schedule, so as to enjoy the immunity protection under the 1986 fascist act (which Senator Kennedy pushed along with other sellout cowards).
They also were planning to give the covid shots the same ridiculous ability to change the shots but not need to be retested, as the shitty flu shots. This was done early to plan it out.
The next step, I felt that pharma would turn up the dial on the shots but sit and rely on the approval as safety. Nope, despite all of this regulatory planning err scamming, the lazy aholes decided to ride the PREP act forever and not even make the "approved" shot, corninarty/spikevax/etc.
I'm also surprised that despite being able to rig studies to make deadly drugs like vioxx look safe, even with "demonstration" purpose, they handed a study that shows clear issues to the FDA for approval. The FDA went and rubber stamped it.
So, instead of Pfizer getting the blame, they can easily point the finger at the FDA etc and say, look we gave them muddy safety results and they decided it was safe, not us! That also explains why it was not advertised by pharma but the media and the corrupt idiot agencies. Both the media and the agencies are the truly guilty ones if this had a chance of facing a case.
Pfizer, etc handed them a piece of shit trial on purpose, instead of faking it as truly safe!
Debunk bro, JJ Couey, and Kevin all suffer from what you wisely described before:
"The evolutionary psychologist William von Hippel found that humans use large parts of thinking power to navigate social world rather than perform independent analysis and decision making. For most people it is the mechanism that, in case of doubt, will prevent one from thinking what is right if, in return, it endangers one’s social status. This phenomenon occurs more strongly the higher a person’s social status. Another factor is that the more educated and more theoretically intelligent a person is, the more their brain is adept at selling them the biggest nonsense as a reasonable idea, as long as it elevates their social status. The upper educated class tends to be more inclined than ordinary people to chase some intellectual boondoggle. "
-Sasha Latypova
You have to get up pretty early in the morning to fool Sasha! Repeat after me "COUNTER MEASURE, COUNTER MEASURE, COUNTER MEASURE!'
NEWS ALERT! Schara v. Ascension Survives Defendants' Final Motion to Dismiss, Moves Directly to Jury Trial
https://therebelpatient.substack.com/p/news-alert-schara-v-ascension-survives
Even after carefully reading this article, it's hard to understand the various legal distinctions. A conspiracist would say this was deliberate ;)
I guess the first thing to know is that even by the FDA, EAU and EUA are sometimes used interchangeably. This makes it hard to tell which category applies. For example, the last slide mentions IND as one of the steps leading to an eventual EUA. By which they really mean EAU?
And it is rather shocking that they have large scale manufacturing coincident with the first step of safety testing, as your yellow box points out. Imagine that the safety testing ended up showing the stuff was very unsafe. But in the meantime they've invested in a lot of large scale manufacturing. If you were a pharmaceutical company and a government that was overseeing all this, what would your reaction be, hmmm? Start over, or sweep the whole thing under the rug? Answer is left to the reader's imagination.
The craziest part about this whole pandemic, mass poisoning is it is in the open, and it just continues. The evidence is ignored, this in itself tells us the system has collapsed. It is not time to fix it but start over. I need to provide some context of our present state of awareness of this issue. I was in large office type meeting yesterday where several comments were made about getting more flu and covid shots. We should not think we are close to a breakthrough of awareness of the masses, it didn't sound like that to me.
Excellent article, Sasha. I’ve arrived at this conclusion: the only thing we can do is simply refuse all these injections, as well as all the prescription drugs foisted upon the population under the false idea that they’ll make people ‘healthier’. They do exactly the opposite, of course…they kill people in slow motion; it’s right there before our eyes in plain sight. in other words, eliminate their customer base. I can’t think of what else to do, as their motivation is all about greed for more $ and control/power. Of course, then they just invent new drugs (absolutely not medicine)to sell…but then I wish folks would refuse all of those, too. It’s breathtaking (and not in a good way) how successful the brainwashing propaganda has been, on so many people. It’s so frustrating.
Hmm? Though I don’t understand the science, the gist of it does make me wonder how much the Smith-Mundt Act has to do with the lies and deceit? Where the original 1948 Act prohibited the “reporting” of government-authorized propaganda on U.S. citizens, Obama’s modernized 2012 version lifted that prohibition.
https://twitter.com/ttavofficial/status/1720556384788357533?s=49&t=Mmj3GzKEAbnnZZjLyjSV8w&fbclid=IwAR2VOnxMNFmDq57vSyrR9n8UVft6s3cZ0FZD8q5yh4O1eRDtBZvwAUHLN7E
https://en.wikipedia.org/wiki/Smith%E2%80%93Mundt_Act
The laws that they have written are so confusing and complex that no one can really truly understand them, even if they are working tirelessly to do so. They are essentially a free ticket for really *smart* criminals to do whatever they want. This bureaucratic criminal legal web seems to have permeated all sectors of government, which government is clearly in bed with large corporations. I doubt we can fix it without burning down the system. Society just always seems to have psychopaths that rise to the top.
What is the answer? The founding fathers tried to prevent it by delegating most powers to the states but that was undermined over a century ago. We are right where we should never have been if it hadn’t been for the “emergency” of war and the need to start federal taxation. Most Americans are too ignorant to want to go back to the original intent of the constitution so we just continue barreling down the same path. More money siphoned off the public and put into the hands of those who should least have it. Eugenicists. War mongers. Pharma. Bankers.
I've told JJ to get in touch with Katherine several times. Even made sure he had her Proton Mail.
I’m not aware of any other Covid skeptic who has asked this question: WHY would it be so important to push the start date of virus spread back several months? In this speculative deep dive, I identified several possible answers to this question.
One of my answers/explanations: The producers of this faux pandemic HAD to have all these excess deaths. The most important parts of the program couldn't commence until the excess deaths happened.
https://billricejr.substack.com/p/the-pandemics-start-date-had-to-be?utm_source=profile&utm_medium=reader2
That VRBPAC meeting quote is a bombshell!
Usually, I point people to the Brook Jackson case, but it is hard for many people to parse the legalese or grasp the argument of the pfizer attorneys. Similarly, although the phrase "shall not constitute a clinical trial" starkly refutes the idea that these were tested for safety or efficacy, it is hard for people to directly grasp the implications of that language. Frankly, it is hard to believe they could even write something so sinister into law but there it is.
This VRBPAC quote is on a whole different level! A guy named DR FINK of all things outlining how great EUA is because they can do whatever they want with no standards!! No informed consent! No regulations!
I sincerely hope that quote will feature prominently in many future criminal trials.
> The mRNA is poison with or without SV40, because it is transfecting cells and nothing positive to health can happen that way. Only damage can result from this.
That last bullet I 100% agree with, and I don’t believe Kevin McKernan or anyone involved in the vial testing activities disagrees with it either.
> That is not to diminish the point that even in the “uncontaminated” form, the mRNA platform is a very dangerous poison and should not be used for any application.
Reply: Thank you Sasha for all you and many others do. JJ Couey's point that the platform is just bad fails to get much traction.
I too am glad and follow intently Kevin Mckernan's substack. I follow many like your self who point out the flaws in this whole process. Katherine Watt and yourself make courageous arguments.
I am not new to this madness. My parents in 1963 leased 200 acres to grow the family beef, milk and eggs without hormones or antibiotics. My parents then were enraged and profoundly concerned that this could happen.
In 1970 I completely exited the corporate food systems. Began growing my own and purchasing what my wife and I didn't grow from local organic/regenerative growers in our area. That commitment has only deepened with the passing years.
In the 1960s and 1970s there was a popular awareness of the hijacking of the food supply. But the need to survive in a corporate culture overwhelmed the movement and "going along to get along" became a way of life.
Now with C-19 people are startled into awareness and wonder how this happened and what can be done. A lot needs to be done. It happened because most citizens went to sleep in the USA.
It will take a lot of work to roll this back. I have doubts that RFKjr, Trump, Vivek Ramaswamy, Biden, or Biden substitute Gov Newsom have the stones to lead a movement to roll this back.
My wife and I worked diligently on Prop 37 to LABLE GMOS in Californina. It was a grass roots movement with very little money and started by an amazing women Pam Leary. But all Corporate Food and AgriBiz had to do to win is spend lots of money in the last few weeks before voting (Second Tues of Nov) and broadcast half truths to prevail.
There are ways forward. They take energetic vigilance, life style changes and absolute support for local organic gardeners and farmers. These changes in our life as citizens of the Earth enhance our immune system, make peace with Climate Change (a bit of a farce, it is really corporate pollution). More can be done that can be outline in other posts.
Well done. Thank you. People have a hard time accepting the legal framework that all counter-measures require are declarations and approvals. No trials, no testing, no quality control and no informed consent. It should not have been possible. Courts might still rule that Geneva conventions and Nuremberg principles still apply despite the legal attempts to circumvent them.
Hot diggity you are the best, Sasha! God damn I love it when you drop some shit like this. Bless you! Keep it comin!
Magnificent in its simplicity, and remarkably well articulated so much so that a layperson can comprehend; and likewise empathize with the horror of it all: 7 in my small town died suddenly since 2021 , others with blood cancers, sudden massive blood clots. The pshychosis of silence is maddening. We all know but dare not say. Maybe someday Sasha you can put togehter a glossary of these acronymns as those used in this paper. I have done so for myself, but your doing would give greater understanding and proper definitions. I wish you would also get invited to the Highwire. I also think a book is in order.