Coronavirus Crisis: Main Thread

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Re: Coronavirus Crisis: Main Thread

Postby stickdog99 » Sun Nov 14, 2021 6:52 pm

Joe Hillshoist » 14 Nov 2021 22:47 wrote:
drstrangelove » 15 Nov 2021 03:20 wrote:

This is the new quarantine camp being built in my city. The video is legit, google maps street view confirms it.

It is being called the 'Centre for National Resilience in Melbourne'. Which is an unfortunate name given Melbourne is one of the Rockefeller Foundations 'Resilient' cities: https://www.melbourne.vic.gov.au/about- ... ities.aspx



That facility is sposed to be for animal importations isn't it?


1,000 bed facility for animal importations?
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Re: Coronavirus Crisis: Main Thread

Postby Joe Hillshoist » Sun Nov 14, 2021 7:22 pm

stickdog99 » 15 Nov 2021 08:52 wrote:
Joe Hillshoist » 14 Nov 2021 22:47 wrote:
drstrangelove » 15 Nov 2021 03:20 wrote:

This is the new quarantine camp being built in my city. The video is legit, google maps street view confirms it.

It is being called the 'Centre for National Resilience in Melbourne'. Which is an unfortunate name given Melbourne is one of the Rockefeller Foundations 'Resilient' cities: https://www.melbourne.vic.gov.au/about- ... ities.aspx



That facility is sposed to be for animal importations isn't it?


1,000 bed facility for animal importations?


If you want to import livestock or pets to Australia right now they stay in that facility.

Australia has had a quarantine program throughout this pandemic. Its been poorly run and ever outbreak we have had can be traced to a failure in that program. We were quarantining people in hotels and paying the owners of those hotels to do it. In the middle of the city. That's a waste of public money and if someone working at the hotel gets infected then they are in the middle of the highest density of people in the country while they travel to and from work.

We have empty detention facilities in this country that are built to contain humans. We built them to lock up refugees and asylum seekers who came here from Indonesia and Sri Lanka by boat. We don't need to build a detention centre at Greenvale to detain people who are opposed to vaccination. We can stick them in the desert or on islands where they can't escape, not the burbs around Broady where everyone hates the cops and government anyway. Those proper detention facilities, you might call them concentration camps, have multiple layers of razorwire with dogs, watchtowers than can be manned with armed guards if necessary and they are extremely difficult to access. The federal government spent half a billion dollars upgrading them six months ago.

That place at Greenvale is easy to get into or out of if you are determined and have some support on the outside. It probably isn't that hard without support on the outside.

I'm willing to bet that most of the people who are spinning out about that place didn't give a fuck about locking children in indefinite detention just cos they had the nerve to want to come here and ask for help and shelter from oppressive arsehole regimes.
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Re: Coronavirus Crisis: Main Thread

Postby Harvey » Sun Nov 14, 2021 9:10 pm

For some time now Twitter have automatically broken any link to Jonathan Cooks website, you have to click on the address bar then press enter to continue to the site. This level of official interuption by Twitter of access to information has rendered Twitter virtually useless. There's a gaping hole in the market for something similar but better.

Anyway, I note that Cook's website itself is currently down. [Now back online]

https://twitter.com/Jonathan_K_Cook/sta ... 1113336839

Jonathan Cook
@Jonathan_K_Cook

Astonishing: the medical literature suggests Pfizer's new treatment for Covid works the same way as ivermectin but does so much less efficiently or safely. Patent-free ivermectin costs pennies; Pfizer's drug is a huge money-spinner for Big Pharma

----

Dr John Campbell (with deadpan sarcasm): 'No one’s saying that the information [about ivermectin's efficacy] has been deliberately hidden away while millions of people have died'


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This he said to me
"The greatest thing
You'll ever learn
Is just to love
And be loved
In return"


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Re: Coronavirus Crisis: Main Thread

Postby drstrangelove » Mon Nov 15, 2021 12:01 am

Joe Hillshoist » Sun Nov 14, 2021 7:22 pm wrote:I'm willing to bet that most of the people who are spinning out about that place didn't give a fuck about locking children in indefinite detention just cos they had the nerve to want to come here and ask for help and shelter from oppressive arsehole regimes.

Inversely I'm willing to bet the majority who do are more than happy to see the same done to those who are a 'dangerous minority' within the society. Thus undermining the very reasons why people would even seek refuge from oppressive regimes in this country. The most unvaxxed communities are first generation/ second regeneration migrant ones. They currently can't enter some public spaces, and when we enter the phase of unvaccinated lockouts instead of lockdowns, these quarantine camps will be for those of them that break rules.
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Re: Coronavirus Crisis: Main Thread

Postby drstrangelove » Mon Nov 15, 2021 1:57 am

Wombaticus Rex » Mon Nov 08, 2021 11:17 am wrote:Even accepting the ad copy for these vaccines at face value -- and that documentation that everyone who plays an expert on TV gets emailed is definitely ad copy -- they're still not going to hold down a winter spike. They don't have the specs for that task, even assuming all these jury-rigged studies are an accurate prediction of real world results. They're especially not going to prevent that with intense economic pressure to get everyone back to work and keep schools open every day like nothing is wrong.

American institutions can no longer bear the costs of treating nCoV like an existential threat, that's been clear for months now. The narrative shift has already been underway for months now, too: "endemic Covid," reframing the problem as ... well, as exactly what it's been since January 2020. A novel respiratory virus transmitting and reproducing more or less at will, to the extent these microbes are powered by an egregore intelligence, and doing so across every continent on Earth.

As has been noted many times in the nearly 300 pages of correspondence, rants and notes here, human beings are very resistant to the reality of phenomena which do not yield like clay to human agency. And this is surely one.

It is telling how blurred the lines are, across public health comms efforts from credentialed experts and celebrity spokesmodels alike, between mitigating secord order effects and eliminating the primary cause. This has engendered a certain schizophrenia, where even quite intelligent people argue and reason from catchphrases and slogans they don't actually believe, and have to surrender altogether at the slightest pressure, forever retreating back to the anemic assertions that we have to do something, and in order to do that something, we all have to do our part.

Meanwhile, the behavior of our ruling class and their expert managers has made it very clear throughout 2021 that this was never about safety, only about liability. It hardly matters how well the vaccines work, just like it hardly matters how well TSA worked. All that matters is that something has been done.

That something is hardly scientific. A rush job non-experiment with zero controls and very little data collection, either. A virus with a low death rate will continue to evolve through the population for decades to come, with minor variations on that same low death rate, and it will be declared defeated by PR fiat. To those who doubt, the great big red laser pointer in the sky will merely circle the same low death rate this has always had, now held up as proof that all this was worth it, that all this worked. And when outbreaks get uncomfortably virulent from time to time, well, that's clearly the fault of the stubborn MAGA holdouts who refused to get vaccinated.

Over time, more and more studies will unravel all of this, and as ever, it will hardly matter. Eventually, everyone whose reputation and fortune was staked on this narrative will be dead, and then mass media will start to reconsider this whole wretched era as the panicked mistake it was. There will be somber documentaries followed by a prestige TV miniseries, and then our blasphemies and heresies will suddenly be gospel, something everyone always knew all along.


I shared similar hope in this sentiment some weeks ago. But as winter comes to the northern hemisphere, I fear that the response is now to double down.

The truth does unfold in time, but only through a communal process which accepts that process can never be complete. As it currently stands the truth is 'known' by a collection of institutions, whose authority is an unrelenting onslaught of propaganda perpetually reinvigorating the unfortnate human proclivity for mimesis. It has detached itself from reality and now fights against it.

If the vaccines aren't working, it's because we haven't had enough of them. If masks aren't working, it's because people aren't wearing two. There can be only one solution, no alternatives. Everything beyond the authoritative view is a conspiracy trying to undermine the greater good. The Truth is pointed out just before dawn and takes evidence in the sun rising, while proof of what is bad is pointed out just before dusk. This is the oldest cycle, the oldest trick, quite literally in any book.

This cannot last for ever, but it can sustain itself for years. Germany had lost the war by 1942, but it took 3 years of pain and suffering to slowly confine the denial of this reality to within its own bunker detached from the society going on above it, and this only with the help of German industrialists behind the scenes. Such is the natural endpoint of choosing to double-down instead of reform.

The ends are completely different between then and now, but the means aren't. And the problem is ultimately the same. The reduction of reality to statistics and control of it given to men and women who have an inability to consider anything which cannot be quantified into data. Anything that is unquantifiable, such as the human condition, what the religious call god, or what agnostics call - that which cannot be known - is attacked relentlessly as unscientific or subjective. As if such things were bad, and didn't create the required understanding for ethical behaviour.

Which is why this breed of authoritarian scientific reductionism is unethical, and responsible for the gravest crimes against humanity in WW2, both in German and Japense society, but others too. Because anything can be justified through quantitative logic. Freezing prisoners of war to death in experiments to find a cure for frostbite, is quantifiably logical thus 'ethical', when you factor in all the German soldiers dying of frostbite on the Eastern front. This abstraction of logic is used now. The unvaccinated are hospitalised at a higher rate than the vaccinated. Thus they take hospital beds away from the vaccinated. Thus it is quantifiably logically 'ethical' to treat the unvaccinated with a seperate set of human rights. . .for the greater good.

Beyond this, atheistic scientific reductionism, in its inability to accept that some things can't be known, or more importantly SHOULDN'T be known, has an inability not to know things. Should we find out what happens when insects eat the faces off live dogs? We won't know unless we find out. They can't not know. They can't not know because they have a spiritual void they must fill in a quest for omnipotence. They can't accept a god, or not knowing with out one, so must become one. It's also this belief which goes hand in hand with the industrial view that humanity has a natural right to dominate nature. That nature is a bunch of unproductive resources yet to be submitted to the will of humans. And that this process is a righteous crusade of freeing ourselves from the shackles of our mother, as opposed to raping her.

This is all the ideology of the modern western oligarchy. And it's no coincidence that since the beginning of the 20th century the primary target for their 'philanthropy' - being the conversion of wealth into power - has been public health and the endowment of the scientific and academic estates.
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Re: Coronavirus Crisis: Main Thread

Postby Wombaticus Rex » Mon Nov 15, 2021 11:31 am

Yes, by "over time" I meant some sunny span between 2030 and 2050, when all this will have long since stopped mattering in the least.

And besides, didn't we build a better, safer world along the way? So what if we had it all wrong, we saved a broken world. Stay tuned for this week's movement schedule by population code, brought to you by NikeNFT.
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Re: Coronavirus Crisis: Main Thread

Postby stickdog99 » Mon Nov 15, 2021 6:50 pm

drstrangelove » 15 Nov 2021 05:57 wrote:
Wombaticus Rex » Mon Nov 08, 2021 11:17 am wrote:Even accepting the ad copy for these vaccines at face value -- and that documentation that everyone who plays an expert on TV gets emailed is definitely ad copy -- they're still not going to hold down a winter spike. They don't have the specs for that task, even assuming all these jury-rigged studies are an accurate prediction of real world results. They're especially not going to prevent that with intense economic pressure to get everyone back to work and keep schools open every day like nothing is wrong.

American institutions can no longer bear the costs of treating nCoV like an existential threat, that's been clear for months now. The narrative shift has already been underway for months now, too: "endemic Covid," reframing the problem as ... well, as exactly what it's been since January 2020. A novel respiratory virus transmitting and reproducing more or less at will, to the extent these microbes are powered by an egregore intelligence, and doing so across every continent on Earth.

As has been noted many times in the nearly 300 pages of correspondence, rants and notes here, human beings are very resistant to the reality of phenomena which do not yield like clay to human agency. And this is surely one.

It is telling how blurred the lines are, across public health comms efforts from credentialed experts and celebrity spokesmodels alike, between mitigating secord order effects and eliminating the primary cause. This has engendered a certain schizophrenia, where even quite intelligent people argue and reason from catchphrases and slogans they don't actually believe, and have to surrender altogether at the slightest pressure, forever retreating back to the anemic assertions that we have to do something, and in order to do that something, we all have to do our part.

Meanwhile, the behavior of our ruling class and their expert managers has made it very clear throughout 2021 that this was never about safety, only about liability. It hardly matters how well the vaccines work, just like it hardly matters how well TSA worked. All that matters is that something has been done.

That something is hardly scientific. A rush job non-experiment with zero controls and very little data collection, either. A virus with a low death rate will continue to evolve through the population for decades to come, with minor variations on that same low death rate, and it will be declared defeated by PR fiat. To those who doubt, the great big red laser pointer in the sky will merely circle the same low death rate this has always had, now held up as proof that all this was worth it, that all this worked. And when outbreaks get uncomfortably virulent from time to time, well, that's clearly the fault of the stubborn MAGA holdouts who refused to get vaccinated.

Over time, more and more studies will unravel all of this, and as ever, it will hardly matter. Eventually, everyone whose reputation and fortune was staked on this narrative will be dead, and then mass media will start to reconsider this whole wretched era as the panicked mistake it was. There will be somber documentaries followed by a prestige TV miniseries, and then our blasphemies and heresies will suddenly be gospel, something everyone always knew all along.


I shared similar hope in this sentiment some weeks ago. But as winter comes to the northern hemisphere, I fear that the response is now to double down.

The truth does unfold in time, but only through a communal process which accepts that process can never be complete. As it currently stands the truth is 'known' by a collection of institutions, whose authority is an unrelenting onslaught of propaganda perpetually reinvigorating the unfortnate human proclivity for mimesis. It has detached itself from reality and now fights against it.

If the vaccines aren't working, it's because we haven't had enough of them. If masks aren't working, it's because people aren't wearing two. There can be only one solution, no alternatives. Everything beyond the authoritative view is a conspiracy trying to undermine the greater good. The Truth is pointed out just before dawn and takes evidence in the sun rising, while proof of what is bad is pointed out just before dusk. This is the oldest cycle, the oldest trick, quite literally in any book.

This cannot last for ever, but it can sustain itself for years. Germany had lost the war by 1942, but it took 3 years of pain and suffering to slowly confine the denial of this reality to within its own bunker detached from the society going on above it, and this only with the help of German industrialists behind the scenes. Such is the natural endpoint of choosing to double-down instead of reform.

The ends are completely different between then and now, but the means aren't. And the problem is ultimately the same. The reduction of reality to statistics and control of it given to men and women who have an inability to consider anything which cannot be quantified into data. Anything that is unquantifiable, such as the human condition, what the religious call god, or what agnostics call - that which cannot be known - is attacked relentlessly as unscientific or subjective. As if such things were bad, and didn't create the required understanding for ethical behaviour.

Which is why this breed of authoritarian scientific reductionism is unethical, and responsible for the gravest crimes against humanity in WW2, both in German and Japense society, but others too. Because anything can be justified through quantitative logic. Freezing prisoners of war to death in experiments to find a cure for frostbite, is quantifiably logical thus 'ethical', when you factor in all the German soldiers dying of frostbite on the Eastern front. This abstraction of logic is used now. The unvaccinated are hospitalised at a higher rate than the vaccinated. Thus they take hospital beds away from the vaccinated. Thus it is quantifiably logically 'ethical' to treat the unvaccinated with a seperate set of human rights. . .for the greater good.

Beyond this, atheistic scientific reductionism, in its inability to accept that some things can't be known, or more importantly SHOULDN'T be known, has an inability not to know things. Should we find out what happens when insects eat the faces off live dogs? We won't know unless we find out. They can't not know. They can't not know because they have a spiritual void they must fill in a quest for omnipotence. They can't accept a god, or not knowing with out one, so must become one. It's also this belief which goes hand in hand with the industrial view that humanity has a natural right to dominate nature. That nature is a bunch of unproductive resources yet to be submitted to the will of humans. And that this process is a righteous crusade of freeing ourselves from the shackles of our mother, as opposed to raping her.

This is all the ideology of the modern western oligarchy. And it's no coincidence that since the beginning of the 20th century the primary target for their 'philanthropy' - being the conversion of wealth into power - has been public health and the endowment of the scientific and academic estates.


I've often mused on Genesis apple story as the defining parable of Western humanity.

The Garden of Eden is the relative paradise of recognition that all life is magic and connected and thus should be respected. It is also the relative paradise of living with a clear recognition that humans are one part of nature while respecting and reveling in the natural cycles of life and the infinite beauty of Earth.

Because of Western man's jealousy of God, Western civilization rejected this paradise by eating from the Tree of Knowledge. Paradise lost in a vain attempt to become God by breeding livestock, enslaving humans, building pyramids, taming lightning, splitting the atom, building robots, creating AI, manipulating DNA, etc.
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Re: Coronavirus Crisis: Main Thread

Postby stickdog99 » Mon Nov 15, 2021 7:11 pm

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Re: Coronavirus Crisis: Main Thread

Postby Harvey » Mon Nov 15, 2021 7:40 pm

The Hebrews and the Christians are only two cultures, there are many other stories. What if Egyptians were the most contented people on Earth? How would we know? Where do our stories from? :shrug:
And while we spoke of many things, fools and kings
This he said to me
"The greatest thing
You'll ever learn
Is just to love
And be loved
In return"


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Re: Coronavirus Crisis: Main Thread

Postby Harvey » Mon Nov 15, 2021 8:07 pm

stickdog99 » Tue Nov 16, 2021 12:11 am wrote:https://twitter.com/tj0057/status/1459640269087940613?s=21


"We are modifying the immune system to a weakened state."

Belligerent Savant » Sun Nov 14, 2021 5:28 pm wrote:
The following interview is a good listen:

https://rumble.com/voz363-lets-try-this-again.html

Dr. Malone: “This is the Largest Experiment Performed on Human Beings in the History of the World.”


Indeed.
And while we spoke of many things, fools and kings
This he said to me
"The greatest thing
You'll ever learn
Is just to love
And be loved
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Then they came for the 'unvaccinated", and I did not speak

Postby Harvey » Mon Nov 15, 2021 8:23 pm

It begins.

https://www.rt.com/sport/540350-austria-lockdown-covid-coronavirus-unvaccinated-gottwald/

‘I am deeply ashamed of our country’: Austria’s greatest Olympian quits political role as lockdown for unvaccinated comes in
15 Nov, 2021 20:45 / Updated 3 hours ago

‘I am deeply ashamed of our country’: Austria’s greatest Olympian quits political role as lockdown for unvaccinated comes in. Felix Gottwald has spoken out as police patrol the streets of Austria to check people are vaccinated. [He] has accused the government of discriminating and dividing by introducing a strict lockdown for the unvaccinated, causing the country's Sports Minister to defend the measures.

As of Monday, around two million Austrians who have not yet received their Covid vaccinations have been thurst into the initial 10-day measures with their country facing a rise in cases and strains on its public health system.

They have received permission to leave their homes only for work or food shopping, with police carrying out spot checks across public spaces to determine vaccination status and dish out fines ranging from €500 ($572) to €1,450 ($1,650) for anyone caught breaching protocol or refusing to comply.

"We are not taking this step lightly but unfortunately it is necessary," said Chancellor Alexander Schallenberg.

It is happening.Austria has announced they will have a lockdown for the unvaccinated.They will have police out on the streets checking peoples papers to see if their medical status allows them to be outside.Imagine telling someone this 1 year ago.
PeterSweden (@PeterSweden7) November 14, 2021


In an open letter voicing his disgust at the move, three-time Olympic and triple world champion Gottwald has resigned from his role as chairman for popular sports while denouncing "division, agitation, [and] discrimination", which he claims are "the government imperatives of the hour".

"After nine official months in this function, I can say that there may be a lot going on in our country, but certainly not about the health and well-being of Austrians and the people living in Austria – and that in the midst of the greatest health crisis," the Nordic combined all-time great continued.

"I am deeply ashamed of our country and, as an Austrian, I am angry, sad and stunned at the same time."

Protests continue into today in Austria to stop the new lockdown.Innsbruck, Austriapic.twitter.com/VVrLNKWvBF
— Aaron Ginn (@aginnt) November 14, 2021


A self-professed "healthy person who uses sensible and sensible measures to contain the pandemic very responsibly", Gottwald took aim at the Minister of Sports, Werner Kogler, and said that he "would have the power to set levers in motion that promote, rather than prevent, exercise and (popular) sport in what is probably the greatest health crisis of our time", with the unvaccinated unable to partake in such activities.

"As an athlete, I have learned to deal with defeat and failure, to learn from them, to develop myself further and to treat myself and others with respect and dignity. I am currently missing these virtues entirely on the part of politics," he stated.

As Gottwald thanked party members and the Bundes-Sport GmbH organization which he was a part of, he admitted that he accepted that he had "failed" in his duties and felt unable to "continue as if I wasn't aware of the unsportsmanlike and unhealthy developments surrounding this pandemic", which he said "is not an option for me."

Amid protests in Austria, Kogler has responded by calling Gottwald's resignation "regrettable" but defending the government's decision.

"As a member of the commission for mass sport, he tried to contribute to the development of a real movement culture in Austria. I really appreciate his commitment in this area," said Kogler.

"In his letter, Felix Gottwald gave his opinion on the measures taken by the Federal Government and the Ministry of Health. I would like to say the following about this: our mission, as a politician, is to protect the population.

Austria's plan to enforce a full lockdown on the unvaccinated is madness.I'm triple(!) vaccinated and I know I can catch/spread the virus.How on earth could it ever work? Total lunacy.
— Professor Karol Sikora (@ProfKarolSikora) November 12, 2021


"The dramatic increase in the number of cases and incidences, especially among unvaccinated people, as well as the heavily strained hospital capacities, prompted the federal government, together with the provincial governors, to adopt far-reaching measures to cope with the pandemic.

"However, these measures also enable a large part of the Austrian population to continue to do sports in sports clubs: this applies to children and young people up to the end of compulsory schooling as well as all those who have decided to have a vaccination or have recovered.

"All those who do not want to be vaccinated can and of course do [play] sports. For the time being, however, they will stay within their own four walls or in public spaces, at a distance from others, so that the risk of infection for themselves and others is minimized.

"The pandemic is far from over. It is now crucial that as many people as possible get vaccinated. In this way, we can protect ourselves and others from infection and serious illnesses."
And while we spoke of many things, fools and kings
This he said to me
"The greatest thing
You'll ever learn
Is just to love
And be loved
In return"


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Re: Coronavirus Crisis: Main Thread

Postby Harvey » Mon Nov 15, 2021 8:45 pm

I wonder if those who were going to involve themselves knew it long before they became locked in, before history was written. I wonder if they had not already prepared their excuses long before it was even a choice. Perhaps it was just easier. The greater good.

[Edit] No. I'm asking myself this.
And while we spoke of many things, fools and kings
This he said to me
"The greatest thing
You'll ever learn
Is just to love
And be loved
In return"


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Re: Coronavirus Crisis: Main Thread

Postby stickdog99 » Mon Nov 15, 2021 8:55 pm

BioNTech's 2019 Annual Report SEC Filing (Risk Factors)

Risks Related to our Financial Condition and Capital Requirements

No mRNA immunotherapy has been approved, and none may ever be approved. mRNA drug development has substantial clinical development and regulatory risks due to the novel and unprecedented nature of this new category of therapeutics.

As a potential new category of therapeutics, to our knowledge, no mRNA immunotherapies have been approved to date by the FDA, EMA or other regulatory agency. Successful discovery and development of mRNA-based (and other) immunotherapies by either us or our collaborators is highly uncertain and depends on numerous factors, many of which are beyond our or their control. To date, there has never been a Phase 3 trial for an mRNA-based product or a commercialized mRNA-based product.
...

Currently, mRNA is considered a gene therapy product by the FDA. Unlike certain gene therapies that irreversibly alter cell DNA and may cause certain side effects, mRNA-based medicines are designed not to irreversibly change cell DNA. Side effects observed in other gene therapies, however, could negatively impact the perception of immunotherapies despite the differences in mechanism. In addition, because no mRNA-based product has been approved, the regulatory pathway in the United States and may other jurisdictions for approval is uncertain. The pathway for an individualized therapy, such as our iNeST mRNA-based immunotherapy where each patient receives a different combination of mRNAs, remains particularly unsettled. The number and design of the clinical and preclinical studies required for the approval of these types of medicines have not been established, may be different from those required for gene therapy products or therapies that are not individualized or may require safety testing like gene therapy products. Moreover, the length of time necessary to complete clinical trials and submit an application for marketing approval by a regulatory authority varies significantly from one pharmaceutical product to the next and may be difficult to predict. ...

In addition, even if we successfully advance one of our product candidates into and through clinical trials, such trials will likely only include a limited number of subjects and limited duration of exposure to our product candidates. As a result, we cannot be assured that adverse effects of our product candidates will not be uncovered when a significantly larger number of patients are exposed to the product candidate. Further, any clinical trials may not be sufficient to determine the effect and safety consequences of taking our product candidates over a multi-year period. ..

We expect the novel nature of our product candidates to create further challenges in obtaining regulatory approval. For example, the FDA and regulatory authorities in other jurisdictions have limited experience with commercial development of several of our technologies. The FDA may require an Advisory Committee to deliberate on the adequacy of the safety and efficacy data to support licensure. The opinion of the Advisory Committee, although not binding, may have a significant impact on our ability to obtain licensure of the product candidates based on the completed clinical trials, as the FDA often adheres to the Advisory Committee’s recommendations. Accordingly, the regulatory approval pathway for our product candidates may be uncertain, complex, expensive and lengthy, and approval may not be certain. ...

Regulatory requirements governing gene and cell therapy products have evolved and may continue to change in the future, and the implications for mRNA-based therapies is unknown. For example, the FDA has established the Office of Tissues and Advanced Therapies within CBER to consolidate the review of gene therapy and related products, and convenes the Cellular, Tissue and Gene Therapies Advisory Committee to advise CBER on its review. In the European Union, mRNA has been characterized as a Gene Therapy Medicinal Product. In certain countries, mRNA therapies have not yet been classified or any such classification is not known to us. Specifically, in Japan, the Pharmaceuticals and Medical Devices Agency has not taken a position on the regulatory classification. Notwithstanding the differences between our mRNA product candidates and gene therapies, the classification of some of our mRNA product candidates as gene therapies in the United States, the European Union and potentially other counties could adversely impact our ability to develop our product candidates, and could negatively impact our platform and our business. For instance, a clinical hold on gene therapy products across the field due to risks associated with altering cell DNA irreversibly may apply to our mRNA product candidates irrespective of the mechanistic differences between gene therapies and mRNA. ...

Our mRNA product candidates are based on novel technologies and any product candidates we develop may be complex and difficult to manufacture. We may encounter difficulties in manufacturing, product release, shelf life, testing, storage, supply chain management or shipping. If we or any of the third-party manufacturers we work with encounter such difficulties, our ability to supply materials for clinical trials or any approved product could be delayed or stopped.

The manufacturing processes for our product candidates are novel and complex. There are no immunotherapies commercialized to date or manufactured at such scale. Due to the novel nature of this technology and limited experience at larger scale production, we may encounter difficulties in manufacturing, product release, shelf life, testing, storage and supply chain management, or shipping. These difficulties could be due to any number of reasons including, but not limited to, complexities of producing batches at larger scale, equipment failure, choice and quality of raw materials and excipients, analytical testing technology, and product instability. In an effort to optimize product features, we have in the past and may in the future make changes to our product candidates in their manufacturing and stability formulation and conditions. This has in the past resulted in and may in the future result in our having to resupply batches for preclinical or clinical activities when there is insufficient product stability during storage and insufficient supply. Insufficient stability or shelf life of our product candidates could materially delay our or our collaborators’ ability to continue the clinical trial for that product candidate or require us to begin a new clinical trial with a newly formulated drug product, due to the need to manufacture additional preclinical or clinical supply. ...

We are utilizing a number of raw materials and exipients that are either new to the pharmaceutical industry or are being employed in a novel manner. Some of these raw materials and excipients have not been scaled to a level to support commercial supply and could experience unexpected manufacturing or testing failures, or supply shortages. Such issues with raw materials and excipients could cause delays or interruptions to clinical and commercial supply of our product candidates. Further, now and in the future one or more of our programs may have a single source of supply for raw materials and excipients.


So please tell me, exactly how did we get from here to "You Lose Your Job, Right to Leave Your Home, Right to Healthcare, Right to Attend College, Right to Attend Public Schools, and Right to Assemble If You Won't Inject Yourself With This Brand New Shit Every Six Months and Twice on Thursdays" in under two years?
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Re: Coronavirus Crisis: Main Thread

Postby Harvey » Mon Nov 15, 2021 9:19 pm

That's a fair question. Not all of those things are happening eveywhere, the point is all of them are happening somewhere.
And while we spoke of many things, fools and kings
This he said to me
"The greatest thing
You'll ever learn
Is just to love
And be loved
In return"


Eden Ahbez
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Re: Coronavirus Crisis: Main Thread

Postby stickdog99 » Mon Nov 15, 2021 10:36 pm

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