There is an imperative to shift focus. Missing from #FreedomConvoy dissent is rule of British Crown/British Empire - architect/head of Great Reset convened via the World Economic Forum platform.
Canadian Civil Liberties Association:
"The federal government has not met the threshold necessary to invoke the Emergencies Act. This law creates a high and clear standard for good reason: the Act allows government to bypass ordinary democratic processes. This standard has not been met.
The Emergencies Act can only be invoked when a situation "seriously threatens the ability of the Government of Canada to preserve the sovereignty, security and territorial integrity of Canada" & when the situation "cannot be effectively dealt with under any other law of Canada."
Governments regularly deal with difficult situations, and do so using powers granted to them by democratically elected representatives. Emergency legislation should not be normalized. It threatens our democracy and our civil liberties."
"The federal government has not met the threshold necessary to invoke the Emergencies Act. This law creates a high and clear standard for good reason: the Act allows government to bypass ordinary democratic processes. This standard has not been met.
The Emergencies Act can only be invoked when a situation "seriously threatens the ability of the Government of Canada to preserve the sovereignty, security and territorial integrity of Canada" & when the situation "cannot be effectively dealt with under any other law of Canada."
Governments regularly deal with difficult situations, and do so using powers granted to them by democratically elected representatives. Emergency legislation should not be normalized. It threatens our democracy and our civil liberties."
Anyone still marvelling at the “warp speed” of development of the Covid19 “vaccines”?
So what’s involved? Here’s a summary from someone who spent more than 35y in the pharmaceutical industry.
It’s not me, by the way.
This person has the experience to back up their view that the required steps simply cannot be done in a year or less. You’ve been lied to & the alleged “vaccines” have not not not been tested at all adequately, but the processes of manufacture are also way outside the guardrails of quality & consistency.
It’s hardly surprising that there have been so many injuries & deaths.
Best wishes
Mike
1. Licensing under the conditional marketing authorisation (CMA) provisions requires submission of a conditional marketing application (CMA) by the company seeking to market the product.
2. Provisions in the CMA do not relieve the EMA from proper review and evaluation of the common technical document (eCTD) as submitted in the application, to assure safety, efficacy, and quality standards are met.
3. The lifecycle of a development programme for a medicinal product begins with pre-clinical assessment of a batch (lot), or batches of the active pharmaceutical ingredient (API) at small (pilot) scale. Batches are typically pre-GMP.
4. Data relating to production must be carefully recorded and collected, including but not limited to, manufacturing processes and procedures, suppliers, service providers (manufacturers – eg Lonza, Oxford BioMedica), material specifications, development protocols, and analytical methods.
5. These data must be included in Module 3 (chemistry, manufacturing & controls) section of the eCTD when any submission is made. Similarly, all data applicable to Module 4 (safety) must be included in any future submission.
6. Regulatory (EMA) evaluation and approval to conduct clinical trials in humans will (should) have been based on these data. Failure to carry out this evaluation, prior to human administration, constitutes gross negligence. The average timescale for this initial stage is 2 to 3 years.
7. For the next stage in the development lifecycle, studies in humans, GMP is mandated for production of all of test material. The batch size will still be small given the relative low number of subjects receiving drug product. Further safety data must be generated for each batch, to confirm there has been no change to the character of the final molecule. At this stage, Module 5 (clinical) data from the studies in humans is added to the eCTD for future submission.
8. It is essential that the phases of clinical trials are carried out sequentially. Phase 1 production used in humans must be proven safe before moving to a larger scale for phase 2 studies within the broader patient population. Ditto for phase 3 studies if scale up is required. There is a regulatory limit to scale up set at a factor of 2.5X the existing batch. When phase 3 studies are complete, all data pertinent to the three Modules of the eCTD must be submitted electronically to yourselves at EMA.
9. This stage of clinical development typically takes 5 to 8 years.
10. Once the eCTD is submitted to EMA, the regulatory clock begins ticking. During this time, all sections of the eCTD are evaluated by suitably qualified staff, and a list of unanswered questions prepared for discussion and resolution with the applicant.
11. A critical element of Module 3 is the integrity of the end-to-end supply chain that has been constructed during the development programme, and its ability to produce product of consistent quality throughout its lifetime. This is based on every manufacturer of drug substance and drug product, as a minimum, applying for a manufacturing authorisation (MA) for the product, and that the product application is successful and added to their existing license.
12. This can only be effected following a thorough inspection and written report by suitably qualified EMA staff, and remediation of any issues raised by the applicant. This typically take 6 to 12 months.
So what’s involved? Here’s a summary from someone who spent more than 35y in the pharmaceutical industry.
It’s not me, by the way.
This person has the experience to back up their view that the required steps simply cannot be done in a year or less. You’ve been lied to & the alleged “vaccines” have not not not been tested at all adequately, but the processes of manufacture are also way outside the guardrails of quality & consistency.
It’s hardly surprising that there have been so many injuries & deaths.
Best wishes
Mike
1. Licensing under the conditional marketing authorisation (CMA) provisions requires submission of a conditional marketing application (CMA) by the company seeking to market the product.
2. Provisions in the CMA do not relieve the EMA from proper review and evaluation of the common technical document (eCTD) as submitted in the application, to assure safety, efficacy, and quality standards are met.
3. The lifecycle of a development programme for a medicinal product begins with pre-clinical assessment of a batch (lot), or batches of the active pharmaceutical ingredient (API) at small (pilot) scale. Batches are typically pre-GMP.
4. Data relating to production must be carefully recorded and collected, including but not limited to, manufacturing processes and procedures, suppliers, service providers (manufacturers – eg Lonza, Oxford BioMedica), material specifications, development protocols, and analytical methods.
5. These data must be included in Module 3 (chemistry, manufacturing & controls) section of the eCTD when any submission is made. Similarly, all data applicable to Module 4 (safety) must be included in any future submission.
6. Regulatory (EMA) evaluation and approval to conduct clinical trials in humans will (should) have been based on these data. Failure to carry out this evaluation, prior to human administration, constitutes gross negligence. The average timescale for this initial stage is 2 to 3 years.
7. For the next stage in the development lifecycle, studies in humans, GMP is mandated for production of all of test material. The batch size will still be small given the relative low number of subjects receiving drug product. Further safety data must be generated for each batch, to confirm there has been no change to the character of the final molecule. At this stage, Module 5 (clinical) data from the studies in humans is added to the eCTD for future submission.
8. It is essential that the phases of clinical trials are carried out sequentially. Phase 1 production used in humans must be proven safe before moving to a larger scale for phase 2 studies within the broader patient population. Ditto for phase 3 studies if scale up is required. There is a regulatory limit to scale up set at a factor of 2.5X the existing batch. When phase 3 studies are complete, all data pertinent to the three Modules of the eCTD must be submitted electronically to yourselves at EMA.
9. This stage of clinical development typically takes 5 to 8 years.
10. Once the eCTD is submitted to EMA, the regulatory clock begins ticking. During this time, all sections of the eCTD are evaluated by suitably qualified staff, and a list of unanswered questions prepared for discussion and resolution with the applicant.
11. A critical element of Module 3 is the integrity of the end-to-end supply chain that has been constructed during the development programme, and its ability to produce product of consistent quality throughout its lifetime. This is based on every manufacturer of drug substance and drug product, as a minimum, applying for a manufacturing authorisation (MA) for the product, and that the product application is successful and added to their existing license.
12. This can only be effected following a thorough inspection and written report by suitably qualified EMA staff, and remediation of any issues raised by the applicant. This typically take 6 to 12 months.
During this time and following a successful inspection, the applicant typically produces 3 batches of stock at the validated scale, in anticipation of approval and launch.
13. The conclusion is that the development programme lifecycle of pre-clinical, clinical, and full-scale production and regulatory evaluation cannot safely be condensed into 12 months or less. Anything less than 5 years would raise eyebrows, and 8 – 10 years a more reasonable expectation.
14. In addition, consider that the SARS-CoV-2 injections are gene therapies, classed under the heading of advanced therapy medicinal products (ATMPs).
15. Procedural advice on the evaluation of advanced therapies specifies the need for a Committee for Advanced Therapies (CAT) to lead the scientific evaluation, stating: “The evaluation of advanced therapy medicinal products often requires very specific expertise, which goes beyond the traditional pharmaceutical field and covers areas bordering on other sectors such as biotechnology and medical devices.”
16. This would further extend the development lifecycle timeline.
13. The conclusion is that the development programme lifecycle of pre-clinical, clinical, and full-scale production and regulatory evaluation cannot safely be condensed into 12 months or less. Anything less than 5 years would raise eyebrows, and 8 – 10 years a more reasonable expectation.
14. In addition, consider that the SARS-CoV-2 injections are gene therapies, classed under the heading of advanced therapy medicinal products (ATMPs).
15. Procedural advice on the evaluation of advanced therapies specifies the need for a Committee for Advanced Therapies (CAT) to lead the scientific evaluation, stating: “The evaluation of advanced therapy medicinal products often requires very specific expertise, which goes beyond the traditional pharmaceutical field and covers areas bordering on other sectors such as biotechnology and medical devices.”
16. This would further extend the development lifecycle timeline.
I don’t know how well this has aged...,
Someone sent it to me just now.
Cheers
Mike
https://rumble.com/vg4inv-michael-yeadon-full-interview-planet-lockdown.html
Someone sent it to me just now.
Cheers
Mike
https://rumble.com/vg4inv-michael-yeadon-full-interview-planet-lockdown.html
Rumble
Michael Yeadon | Full Interview | Planet Lockdown
Interview with Michael Yeadon, former Vice President and Chief Science Officer of Pfizer, where he worked for 16 years. He outlines his position on the pandemic, the vaccine, the issue of variants, bo
🔥1
The comments under this article are outraged & incendiary. Quite right too.
Mike
https://alexberenson.substack.com/p/the-mrna-covid-shots-are-killing/comments
Mike
https://alexberenson.substack.com/p/the-mrna-covid-shots-are-killing/comments
Substack
The mRNA Covid shots are killing teenagers
The journal of the College of American Pathologists has a stunning report today on the cases of two teen boys who died following mRNA Covid vacc…
"The federal government is also going after financial support for illegal activity associated with the convoy protest.
Convoy organizers have raised millions of dollars. They raised money first through the GoFundMe crowdfunding site. When GoFundMe shut the fundraising campaign down, organizers pivoted to the Christian crowdfunding site GiveSendGo.
Finance Minister Chrystia Freeland said that under the Emergencies Act, crowdfunding platforms and the payment service providers they use must register with the Financial Transactions and Reports Analysis Centre of Canada (FINTRAC), the national financial intelligence agency. They must also report large and suspicious transactions to FINTRAC.
"The illegal blockades have highlighted the fact that crowdfunding platforms, and some of the payment service providers they use, are not fully captured under the Proceeds of Crime and Terrorist Financing Act," she said.
"We are making these changes because we know that these platforms are being used to support illegal blockades and illegal activity which is damaging the Canadian economy."
Canadian financial institutions can now temporarily cease providing financial services if the institution suspects an account is being used to further the illegal blockades and occupations, said Freeland.
"This order covers both personal and corporate accounts," she said."
https://www.cbc.ca/news/politics/trudeau-premiers-cabinet-1.6350734
Convoy organizers have raised millions of dollars. They raised money first through the GoFundMe crowdfunding site. When GoFundMe shut the fundraising campaign down, organizers pivoted to the Christian crowdfunding site GiveSendGo.
Finance Minister Chrystia Freeland said that under the Emergencies Act, crowdfunding platforms and the payment service providers they use must register with the Financial Transactions and Reports Analysis Centre of Canada (FINTRAC), the national financial intelligence agency. They must also report large and suspicious transactions to FINTRAC.
"The illegal blockades have highlighted the fact that crowdfunding platforms, and some of the payment service providers they use, are not fully captured under the Proceeds of Crime and Terrorist Financing Act," she said.
"We are making these changes because we know that these platforms are being used to support illegal blockades and illegal activity which is damaging the Canadian economy."
Canadian financial institutions can now temporarily cease providing financial services if the institution suspects an account is being used to further the illegal blockades and occupations, said Freeland.
"This order covers both personal and corporate accounts," she said."
https://www.cbc.ca/news/politics/trudeau-premiers-cabinet-1.6350734
CBC
Federal government invokes Emergencies Act for first time ever in response to protests, blockades | CBC News
Prime Minister Justin Trudeau says he has invoked the Emergencies Act for the first in time in Canada's history to give the federal government extra powers to handle ongoing protests against pandemic restrictions.
Despite being Summer, Covid-19 Deaths are at record levels in Australia and 4 in every 5 of them are among the Fully Vaccinated
The number of people now dying of Covid-19 every day in Australia is 3 times greater than the number who died every day in Australia’s first wave when there were not any Covid-19 injections available to the public…
https://dailyexpose.uk/2022/02/15/australia-4-in-5-covid-deaths-fully-vaccinated
The number of people now dying of Covid-19 every day in Australia is 3 times greater than the number who died every day in Australia’s first wave when there were not any Covid-19 injections available to the public…
https://dailyexpose.uk/2022/02/15/australia-4-in-5-covid-deaths-fully-vaccinated
In November 2021, my friend Dr Thomas Binder wrote, in narrative & personal form, a good summary of “the nonsense”, as he calls it.
Like me, it took some time before he appreciated that what we were being told was all lies.
But there we were & here we are.
If you find it useful to have a great deal of the con summarised in one, readable piece, you might consider sharing it with others on your circle including, if you are still talking to any, those who still believe the fairy stories.
Best wishes,
Mike
https://www.thomasbinder.ch/post/the-prevailing-corona-nonsense-narrative
Like me, it took some time before he appreciated that what we were being told was all lies.
But there we were & here we are.
If you find it useful to have a great deal of the con summarised in one, readable piece, you might consider sharing it with others on your circle including, if you are still talking to any, those who still believe the fairy stories.
Best wishes,
Mike
https://www.thomasbinder.ch/post/the-prevailing-corona-nonsense-narrative
Humanismus 2020
The prevailing corona nonsense narrative
All myths of the prevailing corona narrative are made up out of a fact-free vacuum.
Forwarded from Dr. Simon
This media is not supported in your browser
VIEW IN TELEGRAM
German TV presenter pushes for further enforcements of the general vax mandate, then collapses live on air due to climate change.
https://t.me/goddek
https://t.me/goddek
Forwarded from Chief Nerd
Media is too big
VIEW IN TELEGRAM
Forbes contributor of ten years says he was fired over investigative stories on Fauci
https://video.foxnews.com/v/6297540541001#sp=show-clips
@ChiefNerd
https://video.foxnews.com/v/6297540541001#sp=show-clips
@ChiefNerd
So, 3 of 3 former heads of FDA & MHRA joined Pfizer’s board, the venture financier behind Moderna & the Bill & Melinda Gates Foundation. Nothing to see here, folks.
Seriously, if these moves are legal, then the regulations intending to prevent corruption are hopelessly ineffective.
Mike
https://hedleyrees.substack.com/p/pharma-regulatory-revolving-doorsalarm
Seriously, if these moves are legal, then the regulations intending to prevent corruption are hopelessly ineffective.
Mike
https://hedleyrees.substack.com/p/pharma-regulatory-revolving-doorsalarm
Substack
PHARMA REGULATORY REVOLVING DOORS—ALARM BELLS MUST START RINGING NOW
Only politicians can stop it
It’ll be hard to top these three well remunerated new posts by former Medicines Agencies heads.
Really shouldn’t be permitted for at least a year after leaving certain sensitive posts.
Mind you, if they stuck by a rule, the named individuals would simply “consult” for a year as “special advisor”.
Once a society loses its shame at such obviously bent behaviour, there’s little point in even having a drugs regulator.
I used to tell people that, if duly approved by FDA or MHRA, you could rely on the basic claims about a medical treatment being properly underwritten.
Such was once my respect for those in the worlds top two medicines regulators.
Now, I assume they’re lying unless independent verification is at hand.
This are not the drugs regulators or the R&D based pharmaceutical industry I joined in the 1980s.
They’re all gone, replaced by incompetence & corruption, in one of the few truly vital areas of life.
Total corruption calls for these regulators to be razed to the ground, virtually of course.
The MHRA for example, cannot be mended in its current form.
A recent analysis of the skill sets & backgrounds of the entire executive team at MHRA showed them to lack the training & experience on the basis of which a drug is approved (or not).
This is unbelievably serious because it means what a lay person would guess. Nothing which gains an approval from any of these shops these days is safe to use.
So if you’re prescribed a drug which gained its license only recently (last five years or so, possibly a little earlier) isn’t something that can be recommended.
Way too much money involved for these corrupt rats to even consider your health & safety.
My contempt for these formerly well run institutions knows no bounds.
Not everyone who worked or works in new drug R&D is corrupt. But far too many now are, at the senior levels, for there to be any trust.
Spitting tacks here.
Mike
https://hedleyrees.substack.com/p/pharma-regulatory-revolving-doorsalarm/comments
Really shouldn’t be permitted for at least a year after leaving certain sensitive posts.
Mind you, if they stuck by a rule, the named individuals would simply “consult” for a year as “special advisor”.
Once a society loses its shame at such obviously bent behaviour, there’s little point in even having a drugs regulator.
I used to tell people that, if duly approved by FDA or MHRA, you could rely on the basic claims about a medical treatment being properly underwritten.
Such was once my respect for those in the worlds top two medicines regulators.
Now, I assume they’re lying unless independent verification is at hand.
This are not the drugs regulators or the R&D based pharmaceutical industry I joined in the 1980s.
They’re all gone, replaced by incompetence & corruption, in one of the few truly vital areas of life.
Total corruption calls for these regulators to be razed to the ground, virtually of course.
The MHRA for example, cannot be mended in its current form.
A recent analysis of the skill sets & backgrounds of the entire executive team at MHRA showed them to lack the training & experience on the basis of which a drug is approved (or not).
This is unbelievably serious because it means what a lay person would guess. Nothing which gains an approval from any of these shops these days is safe to use.
So if you’re prescribed a drug which gained its license only recently (last five years or so, possibly a little earlier) isn’t something that can be recommended.
Way too much money involved for these corrupt rats to even consider your health & safety.
My contempt for these formerly well run institutions knows no bounds.
Not everyone who worked or works in new drug R&D is corrupt. But far too many now are, at the senior levels, for there to be any trust.
Spitting tacks here.
Mike
https://hedleyrees.substack.com/p/pharma-regulatory-revolving-doorsalarm/comments
Substack
PHARMA REGULATORY REVOLVING DOORS—ALARM BELLS MUST START RINGING NOW
Only politicians can stop it
Fully Vaccinated account for 7 in every 10 Covid-19 Deaths across Canada according to Government of Canada data
Covid-19 deaths across Canada are currently exceeding the numbers recorded in previous waves when there were not any Covid-19 vaccines available to the public and the majority of those dying are fully vaccinated…
https://dailyexpose.uk/2022/02/15/canada-covid-deaths-70-percent-vaccinated/
Covid-19 deaths across Canada are currently exceeding the numbers recorded in previous waves when there were not any Covid-19 vaccines available to the public and the majority of those dying are fully vaccinated…
https://dailyexpose.uk/2022/02/15/canada-covid-deaths-70-percent-vaccinated/
https://pubmed.ncbi.nlm.nih.gov/34785268/
This is for those who want children to wear masks forever.
Think about it. If even immunocompromised kids aren’t at risk, it’s hardly a surprise to find that previously healthy children aren’t, either.
It’s not as if we didn’t know this. Numerous countries with good records have shown us that kids simply don’t die as a result of this alleged virus.
Best wishes
Mike
This is for those who want children to wear masks forever.
Think about it. If even immunocompromised kids aren’t at risk, it’s hardly a surprise to find that previously healthy children aren’t, either.
It’s not as if we didn’t know this. Numerous countries with good records have shown us that kids simply don’t die as a result of this alleged virus.
Best wishes
Mike
Forwarded from AAA Cercasi Democrazia
In Italy, from today, those over 50 years old have the obligation to be vaccinated. 3 doses!
Or he will be persecuted.
Starting with a fine of € 1500 if he is a worker. TELL ME IF THIS CAN BE CALLED DEMOCRACY.
Be our ambassadors around the world. Because everything is CENSORED
Or he will be persecuted.
Starting with a fine of € 1500 if he is a worker. TELL ME IF THIS CAN BE CALLED DEMOCRACY.
Be our ambassadors around the world. Because everything is CENSORED