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.
Sasha you are spot on about these shots being listed as “ Countermeasures “ in the legislation. Here is a bulletin that came out Nov 14th in regards to the Biden Administration hiring more lawyers in defence of vaccine lawsuits.
“ It’s unclear if the attorneys the Biden administration is hiring will be responsible for COVID-19 vaccine claims. COVID-19 vaccines are covered under the Countermeasures Injury Compensation Program (CICP), not the National Vaccine Injury Compensation Program (VICP), according to the Health Resources and Services Administration. Vaccines covered under the VICP include tetanus, measles, mumps and rubella, and polio.”
So let's summarise this in simple, no-holds-barred language:
1. The Powers that Be 'created a pandemic' by changing the definition of a pandemic in late 2019, so that SARS-CoV2 could be called a 'pandemic'.
2. They imposed unprecedented restrictions on human life due to this 'artificially created pandemic' with the express aim of destroying tens of millions of small-medium-sized businesses across the globe, to grossly affect the education of children worldwide and to distort hundreds of millions of honorably entered-into loans, most notably for homebuyers.
3. They trashed the investigation of all cheap, off-patent already licensed drugs with up to 50 years of patient data for the treatment of Covid19 symptoms, since that would not make the pharmaceutical mafia hundreds of billions of dollars.
4. They imposed on everyone (through unprecedented MSM pressure) who submitted to their propaganda the need to be vaccinated by the most un-tested, most evidence-free concoctions using technology never before used in humans.
5. They provided blanket immunity for the contract manufacturers of these uncharacterised potions.
6. They imposed employment discrimination against vast numbers of compos mentis workers who sensibly refused to be injected with unknown concoctions.
7. They smeared everyone with media traction who questioned the absurdity of what they were doing.
8. They made global plans for the transfer of all health power globally to the WHO, aiming to remove all oversight for human health from nationally elected governments.
9. They kept pushing repeated vaccinations until it become abundantly clear to billions that the vaccinations did no good, increasingly caused harm and were causing harm to those people with the most life years to lose (namely the healthy U40s and children).
10. Having realised that the Covid19 vaccine scam was dead, they arranged for the pharmaceutical mafia to claim they had 'reinvented ivermectin' by patenting mimics of the smeared horse dewormer and then thinking they could sell them to treat Covid for about 100 times the price of ivermectin.
11. They took on long-term manufacturing supply contracts for mRNA vaccines, basically telling the suppliers that they could come up with plenty more ways to kill people and get paid billions in profits for their troubles.
12. And now, this week, their political f**k wit drones send me an email saying that 'the next election is about control of finances vs going on a spending spree'. I ask you: those that spaffed $300bn in a year on useless PPI products, on shutting down the economy, on poison jabs and more besides, start to talk about 'long-term decision making for the good of society'? And they get the King to read that claptrap in his 'Opening of Parliament' 'My Government will.....' speech?
What we have are shameless liars, career criminals and organised gangsters all with their trotters in the trough, guzzling the gravy train of opportunity with impunity.
Old politics is dead, old medicine is dead, old media is dead and old science is dead.
From now on, anyone who wants health and happiness has to take responsibility to maintain it for themselves.
You won't get it from old politicians, old doctors, nor the TV.
If you want Governments to help in that regard, you have to help yourselves and vote for people who aren't bought by AIPAC, Big Pharma, the arms cabal nor Wall Street.
Good luck and expect a few sudden deaths if you get too successful at it.....
You are a great Artist twice over. With both paint and words you deliver basic, primal clarity.
Your canvases please my soul and deepen my smile. Your words pare away bureaucratic "pseudo" legalese to lay bare the barbaric, unequivocal, intentionality of this democide.
When the populace figures it all out, the bud light treatment will work. The populace needs to understand and accept the fraud of the not so safe and effective injections. Unfortunately, it will take deaths and disabilities of their family and loved ones before the populace accepts they have been 'had". I am afraid the courts are useless. Only education will work and the school of hard knocks appears to be the classroom. Sasha, you and Katherine are superior instructors! Keep educating the populace. Thank you.
Sasha - Your article simultaneously completely misunderstands JJ’s main point while totally proving it. You have spent way too much time in Regulatory LaLa Land (I say that as a former fellow LaLa resident who once had to provide legal replies to “what’s the impact on background radiation from a nuclear power plant hit by a thermonuclear bomb or one hit by a glacier?”). Normal people don’t think in regulatoriese. It is great that you do and I thank you profusely for you efforts, but as you know much better than I, LaLa land is not reality.
To think that JJ’s key argument is about an incredibly nuanced regulatory comment, misses his key argument. JJ’s main point was that the “Plasmids in a Bottle” argument is just another distraction, like virtually everything during the “Covid Crisis”, to hide the real issues. To spend an entire highly informative and insightful article parsing the finer shades of regulatory gray proves his point.
Basically, JJ’s point is ‘Is what we just went through real?”
Is gain of function real?
- Can a mRNA virus naturally replicate accurately enough without rapidly degrading so much that it is no longer infectious?
- Was the Covid virus so unstable that something else was needed to create the appearance of a deadly pandemic to scare the straights shitless, controllable, and brain dead enough to inject Fauxi’s Magic Juice? (“A pandemic of the Unvaxxed” -ask someone, anyone, to explain that logical impossibility)
- Was that additional fear factor really created by the mass manufacture and controlled release of replicate-competent Covid viruses created though the Plasmids manufacturing techniques described?
- If this crisis was caused by releasing Swarms of manufactured Covid viruses, who, what, where, when, and how?
- Was stoping successful early treatments, fraudulent PCR and LF tests, Remdesivir, limiting antibiotics and steroids, ventilators, overuse of opioids, hospital patients isolation and mistreatment, Do Not Resuscitate Orders, and falsifying Death Certificates (many of which had massive Federal subsidies and liability protections) the Real cause of the “Pandemic?”
All of this is from JJ work. Is the critical issue really EUA vs EAU? Or it is the answers to these questions? That’s JJ’s point.
For those that wonder how I answered the nuke vs bomb or vs glacier questions, they are both unreal and irrelevant. Like much of Regulatory LaLa Land.
my article is not about covid virus. In fact I stated pretty clearly in the article that it was a hoax perpetrated by the US military-intelligence agencies. However, what I discuss in my article is unrelated to existence or non-existence of covid virus, disease or GOF. The government fraud and mass murder enabling "legal" frameworks must be dismantled REAGRDLESS of whether covid exists or not, GOF exists or not, and whether those things are dangerous or not.
hi, and txs for pointing out: my point was, his book "the lies my gov told me" etc, and his deep analysis of modmrna, etc, world gov actions, dont get to the heart of the issue, the great evil actuating these events, what you point out, namely, these are poisons, sanctified by govs, just as fentanyl is, wontonly deliberately. Malone, Kirsch, et al are looking at the outside. txs
You sure know how to wade through the BS and hone in on the Truth. It also kinda helps that you can't be bought off. Live very long and healthy, Sasha!
Doesn't matter who did what, nobody is going to prison or being hanged in the streets...and that's the damnable misery of this whole murder operation that will continue unabated.
Indeed........ a very good "master class " . Well done Sasha . ( no sarcasm)
Only some realism. Or, cynicsm as some like to call it . Because really ...when the COURT is corrupted to the point where the interpretations and manipulations are all totally controlled by the judge and jury , who just happen to be the defendents, well.......... "what now ? "
"hope is the last one to die on this planet " . Good time for a new save the world comic book hero :
HOPE ! Might be a SMASHING success . ( walt disney producer ?? )
As always, Sasha, your work is astounding! Could I ask a teensy favor -- OK, maybe a BIG one:
Within each article (or in a separate post and then just link to that post), please include a list of most-used -- but lesser-known outside the industry -- acronyms, their written-out text, and a "best" link to additional legal/FDA information. I'm forever forgetting what these terms mean.
Examples of some acronyms used in this article (please correct any misinformation or incorrect links):
I am not arguing that this would be helpful, but I already work 80+ hours a week and have to travel and write testimonies for court. I generally spell out what acronyms mean (that's my practice, anyway) and I advise the readers to also use internet by themselves. I am not complaining, simply "cGMP" is very easy to search and see what it is. Expanded access use - same, PREP Act - same. None of these are very technical terms. I expect my readers to have at least a little bit of engagement in their own education on this matter.
I understand how busy you are. But I’ve been studying this stuff for nearly 4 years and still have to look some of it up. PLUS, I share with others who are not educated (yet).
So no worries if you can’t accommodate this request.
Here’s my thought: Create ONE master post — perhaps calling it “Definitions and Acronyms” or something Sasha-Snarky — that you update as needed and as time permits. Then, at the top or bottom of an individual post, simply link to the master post.
Example: My obscure Substack has a linked “master post” page at the top called “Covid” which opens an often-updated page called “Covid Essential Links” (with the date of most recent update). Then, individual posts simply link to the master post. You do the work just once, then repeatedly link to that work in your individual posts.
With this method, your extra work is minimal. The experienced readers don’t have to wade through the written-out acronyms they already know, and the newbies can find just what they need.
Sasha you are spot on about these shots being listed as “ Countermeasures “ in the legislation. Here is a bulletin that came out Nov 14th in regards to the Biden Administration hiring more lawyers in defence of vaccine lawsuits.
“ It’s unclear if the attorneys the Biden administration is hiring will be responsible for COVID-19 vaccine claims. COVID-19 vaccines are covered under the Countermeasures Injury Compensation Program (CICP), not the National Vaccine Injury Compensation Program (VICP), according to the Health Resources and Services Administration. Vaccines covered under the VICP include tetanus, measles, mumps and rubella, and polio.”
So let's summarise this in simple, no-holds-barred language:
1. The Powers that Be 'created a pandemic' by changing the definition of a pandemic in late 2019, so that SARS-CoV2 could be called a 'pandemic'.
2. They imposed unprecedented restrictions on human life due to this 'artificially created pandemic' with the express aim of destroying tens of millions of small-medium-sized businesses across the globe, to grossly affect the education of children worldwide and to distort hundreds of millions of honorably entered-into loans, most notably for homebuyers.
3. They trashed the investigation of all cheap, off-patent already licensed drugs with up to 50 years of patient data for the treatment of Covid19 symptoms, since that would not make the pharmaceutical mafia hundreds of billions of dollars.
4. They imposed on everyone (through unprecedented MSM pressure) who submitted to their propaganda the need to be vaccinated by the most un-tested, most evidence-free concoctions using technology never before used in humans.
5. They provided blanket immunity for the contract manufacturers of these uncharacterised potions.
6. They imposed employment discrimination against vast numbers of compos mentis workers who sensibly refused to be injected with unknown concoctions.
7. They smeared everyone with media traction who questioned the absurdity of what they were doing.
8. They made global plans for the transfer of all health power globally to the WHO, aiming to remove all oversight for human health from nationally elected governments.
9. They kept pushing repeated vaccinations until it become abundantly clear to billions that the vaccinations did no good, increasingly caused harm and were causing harm to those people with the most life years to lose (namely the healthy U40s and children).
10. Having realised that the Covid19 vaccine scam was dead, they arranged for the pharmaceutical mafia to claim they had 'reinvented ivermectin' by patenting mimics of the smeared horse dewormer and then thinking they could sell them to treat Covid for about 100 times the price of ivermectin.
11. They took on long-term manufacturing supply contracts for mRNA vaccines, basically telling the suppliers that they could come up with plenty more ways to kill people and get paid billions in profits for their troubles.
12. And now, this week, their political f**k wit drones send me an email saying that 'the next election is about control of finances vs going on a spending spree'. I ask you: those that spaffed $300bn in a year on useless PPI products, on shutting down the economy, on poison jabs and more besides, start to talk about 'long-term decision making for the good of society'? And they get the King to read that claptrap in his 'Opening of Parliament' 'My Government will.....' speech?
What we have are shameless liars, career criminals and organised gangsters all with their trotters in the trough, guzzling the gravy train of opportunity with impunity.
Old politics is dead, old medicine is dead, old media is dead and old science is dead.
From now on, anyone who wants health and happiness has to take responsibility to maintain it for themselves.
You won't get it from old politicians, old doctors, nor the TV.
If you want Governments to help in that regard, you have to help yourselves and vote for people who aren't bought by AIPAC, Big Pharma, the arms cabal nor Wall Street.
Good luck and expect a few sudden deaths if you get too successful at it.....
Beware, 👺🥼+☣️💉= can produce sudden death syndrome!
You are a great Artist twice over. With both paint and words you deliver basic, primal clarity.
Your canvases please my soul and deepen my smile. Your words pare away bureaucratic "pseudo" legalese to lay bare the barbaric, unequivocal, intentionality of this democide.
When the populace figures it all out, the bud light treatment will work. The populace needs to understand and accept the fraud of the not so safe and effective injections. Unfortunately, it will take deaths and disabilities of their family and loved ones before the populace accepts they have been 'had". I am afraid the courts are useless. Only education will work and the school of hard knocks appears to be the classroom. Sasha, you and Katherine are superior instructors! Keep educating the populace. Thank you.
Russia releases 2000 page report that the Deep State created Covid!!
https://rumble.com/v3axptu-russia-release-damning-2000-page-report-proving-covid-was-a-globalist-biowe.html
I'm starting to figure that you are right on them!
https://twitter.com/dorienrose/status/1712755334148731367?s=21&t=TreBg2fyDwaD9hmMPik3xQ
do you have a copy of this letter? It has been taken down on the EU website.
https://marceldegraaff.nl/covid-vaccins-illegaal-goedgekeurd/
I guess it's this one:
https://marceldegraaff.nl/covid-vaccins-illegaal-goedgekeurd/
Sasha - Your article simultaneously completely misunderstands JJ’s main point while totally proving it. You have spent way too much time in Regulatory LaLa Land (I say that as a former fellow LaLa resident who once had to provide legal replies to “what’s the impact on background radiation from a nuclear power plant hit by a thermonuclear bomb or one hit by a glacier?”). Normal people don’t think in regulatoriese. It is great that you do and I thank you profusely for you efforts, but as you know much better than I, LaLa land is not reality.
To think that JJ’s key argument is about an incredibly nuanced regulatory comment, misses his key argument. JJ’s main point was that the “Plasmids in a Bottle” argument is just another distraction, like virtually everything during the “Covid Crisis”, to hide the real issues. To spend an entire highly informative and insightful article parsing the finer shades of regulatory gray proves his point.
Basically, JJ’s point is ‘Is what we just went through real?”
Is gain of function real?
- Can a mRNA virus naturally replicate accurately enough without rapidly degrading so much that it is no longer infectious?
- Was the Covid virus so unstable that something else was needed to create the appearance of a deadly pandemic to scare the straights shitless, controllable, and brain dead enough to inject Fauxi’s Magic Juice? (“A pandemic of the Unvaxxed” -ask someone, anyone, to explain that logical impossibility)
- Was that additional fear factor really created by the mass manufacture and controlled release of replicate-competent Covid viruses created though the Plasmids manufacturing techniques described?
- If this crisis was caused by releasing Swarms of manufactured Covid viruses, who, what, where, when, and how?
- Was stoping successful early treatments, fraudulent PCR and LF tests, Remdesivir, limiting antibiotics and steroids, ventilators, overuse of opioids, hospital patients isolation and mistreatment, Do Not Resuscitate Orders, and falsifying Death Certificates (many of which had massive Federal subsidies and liability protections) the Real cause of the “Pandemic?”
All of this is from JJ work. Is the critical issue really EUA vs EAU? Or it is the answers to these questions? That’s JJ’s point.
For those that wonder how I answered the nuke vs bomb or vs glacier questions, they are both unreal and irrelevant. Like much of Regulatory LaLa Land.
my article is not about covid virus. In fact I stated pretty clearly in the article that it was a hoax perpetrated by the US military-intelligence agencies. However, what I discuss in my article is unrelated to existence or non-existence of covid virus, disease or GOF. The government fraud and mass murder enabling "legal" frameworks must be dismantled REAGRDLESS of whether covid exists or not, GOF exists or not, and whether those things are dangerous or not.
Brilliant, thanks -- I think I finally get it.
"They are illicit poisons which are trafficked the same way fentanyl or heroin are trafficked world wide (and probably by the same main actors)."
It seems like we have RICO crimes here just as we do with all other illegal drugs. Why can honest AGs prosecute using existing drug and fraud laws?
hi, and txs for pointing out: my point was, his book "the lies my gov told me" etc, and his deep analysis of modmrna, etc, world gov actions, dont get to the heart of the issue, the great evil actuating these events, what you point out, namely, these are poisons, sanctified by govs, just as fentanyl is, wontonly deliberately. Malone, Kirsch, et al are looking at the outside. txs
You sure know how to wade through the BS and hone in on the Truth. It also kinda helps that you can't be bought off. Live very long and healthy, Sasha!
Doesn't matter who did what, nobody is going to prison or being hanged in the streets...and that's the damnable misery of this whole murder operation that will continue unabated.
Indeed........ a very good "master class " . Well done Sasha . ( no sarcasm)
Only some realism. Or, cynicsm as some like to call it . Because really ...when the COURT is corrupted to the point where the interpretations and manipulations are all totally controlled by the judge and jury , who just happen to be the defendents, well.......... "what now ? "
"hope is the last one to die on this planet " . Good time for a new save the world comic book hero :
HOPE ! Might be a SMASHING success . ( walt disney producer ?? )
As always, Sasha, your work is astounding! Could I ask a teensy favor -- OK, maybe a BIG one:
Within each article (or in a separate post and then just link to that post), please include a list of most-used -- but lesser-known outside the industry -- acronyms, their written-out text, and a "best" link to additional legal/FDA information. I'm forever forgetting what these terms mean.
Examples of some acronyms used in this article (please correct any misinformation or incorrect links):
* cGxP - Current Good Practice; The ‘x’ can be swapped out for other letters to stand for a variety of disciplines. Example: CGMP is Current Good Manufacturing Practices (where Manufacturing is swapped out for 'x') (https://en.wikipedia.org/wiki/GxP, https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-manuals/compliance-program-manual)
* EAU - Expanded Access Use (https://www.fda.gov/news-events/expanded-access/expanded-access-categories-drugs-including-biologics)
* EUA - Emergency Use Authorization (https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization)
* IND - Investigational New Drug (https://www.fda.gov/news-events/expanded-access/expanded-access-categories-drugs-including-biologics)
* PHE - Public Health Emergency (https://aspr.hhs.gov/legal/PHE/Pages/default.aspx)
* PREP Act - Public Readiness and Emergency Preparedness Act (https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#prepact)
I am not arguing that this would be helpful, but I already work 80+ hours a week and have to travel and write testimonies for court. I generally spell out what acronyms mean (that's my practice, anyway) and I advise the readers to also use internet by themselves. I am not complaining, simply "cGMP" is very easy to search and see what it is. Expanded access use - same, PREP Act - same. None of these are very technical terms. I expect my readers to have at least a little bit of engagement in their own education on this matter.
I understand how busy you are. But I’ve been studying this stuff for nearly 4 years and still have to look some of it up. PLUS, I share with others who are not educated (yet).
So no worries if you can’t accommodate this request.
I will spell out as much as I can.
Here’s my thought: Create ONE master post — perhaps calling it “Definitions and Acronyms” or something Sasha-Snarky — that you update as needed and as time permits. Then, at the top or bottom of an individual post, simply link to the master post.
Example: My obscure Substack has a linked “master post” page at the top called “Covid” which opens an often-updated page called “Covid Essential Links” (with the date of most recent update). Then, individual posts simply link to the master post. You do the work just once, then repeatedly link to that work in your individual posts.
With this method, your extra work is minimal. The experienced readers don’t have to wade through the written-out acronyms they already know, and the newbies can find just what they need.