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.
 

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

The comments under this article are outraged & incendiary. Quite right too.
Mike

https://alexberenson.substack.com/p/the-mrna-covid-shots-are-killing/comments

"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

Useful to see in writing what the threshold is for these powers.
Way higher than the facts on the ground.
Best wishes
Mike

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

I’ll just leave this here.

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

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

Forbes contributor of ten years says he was fired over investigative stories on Fauci

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

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

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/

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

Sy updates on the UKFreedomConvoy. Part of their mission is to highlight the Hammersmith case 6029679/21

#UKFreedomConvoy are standing in solidarity with our Canadian brothers and sisters against mandates, 💉 passports, digital ID, and for every man and woman to do what they want with their bodies and their lives.

Come down and join them in a tent, car, van, whatever.

Follow them here
https://t.me/BoxCleverArmy
https://t.me/UK_Convoy_2022

If you're heading into London to support those in the #UKFreedomConvoy protest then head for Scotland Yard on Victoria Embankment, not far from Parliament/Big Ben. Nearest tube stations are Westminster (2min walk) & Embankment (8min walk)
https://goo.gl/maps/D5MteygvFg9Vaag36

Postcode for SatNav: SW1A 2JH