https://investors.biontech.de/node/8746/html

https://archive.is/5tqlt

BioNTech FORM 6-K

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 commercialized mRNA-based product.

Our product candidates that appear promising in the early phases of development may fail to advance, experience delays in the clinic or clinical holds, or fail to reach the market for many reasons, including:

• discovery efforts aimed at identifying potential immunotherapies may not be successful;

• nonclinical or preclinical study results may show product candidates to be less effective than desired or have harmful or problematic side effects;

• clinical trial results may show the product candidates to be less effective than expected, including a failure to meet one or more endpoints or have unacceptable side effects or toxicities;

• manufacturing failures or insufficient supply of GMP materials for clinical trials, or higher than expected cost could delay or set back clinical trials, or make our product candidates commercially unattractive;

• our improvements in the manufacturing processes may not be sufficient to satisfy the clinical or commercial demand of our product candidates or regulatory requirements for clinical trials;

• changes that we make to optimize our manufacturing, testing or formulating of GMP materials could impact the safety, tolerability and efficacy of our product candidates;

• pricing or reimbursement issues or other factors could delay clinical trials or make any immunotherapy uneconomical or noncompetitive with other therapies;

• the failure to timely advance our programs or receive the necessary regulatory approvals, or a delay in receiving such approvals, due to, among other reasons, slow or failure to complete enrollment in clinical trials, withdrawal by trial participants from trials, failure to achieve trial endpoints, additional time requirements for data analysis, data integrity issues, BLA, MAA or the equivalent application, discussions with the FDA or the EMA, a regulatory request for additional nonclinical or clinical data, or safety formulation or manufacturing issues may lead to our inability to obtain sufficient funding; and

• the proprietary rights, products and technologies of our competitors may prevent our immunotherapies from being commercialized.

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.

…

Long document, there could be other nuggets hiding in plain sight.

>>12143951

Even if regulatory approval is received for a BNT162 vaccine candidate, the later discovery of previously unknown problems associated with BNT162 may result in restrictions, including withdrawal of the product from the market, and lead to significant liabilities and reputational damage.

Because the path to marketing approval of any vaccine against COVID-19 is unclear, we may have a widely used vaccine in circulation in the United States or another country prior to our receipt of marketing approval.

Unexpected safety issues, including any that we have not yet observed in our Phase 1/2 clinical trials for BNT162, could lead to significant reputational damage for BioNTech and our technology platforms going forward and other issues, including delays in our other programs, the need for re-design of our clinical trials and the need for significant additional financial resources.

We also may be restricted or prohibited from marketing or manufacturing a BNT162 vaccine, even after obtaining product approval, if previously unknown problems with the product or its manufacture are subsequently discovered.

We cannot provide assurance that newly discovered or developed safety issues will not arise following regulatory approval. With the use of any vaccine by a wide patient population, serious adverse events may occur from time to time that did not arise in the clinical trials of the product or that initially appeared to be unrelated to the vaccine itself and only with the collection of subsequent information were found to be causally related to the product.

Any such safety issues could cause us to suspend or cease marketing of our approved products, possibly subject us to substantial liabilities, and adversely affect our ability to generate revenue and our financial condition.

…

Our product candidates may not work as intended, may cause undesirable side effects or may have other properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences following marketing approval, if any.

As with most biological products, use of our product candidates could be associated with side effects or adverse events which can vary in severity from minor reactions to death and in frequency from infrequent to prevalent.

The potential for adverse events is especially acute in the oncology setting, where patients may have advanced disease, have compromised immune and other systems and be receiving numerous other therapies.

Undesirable side effects or unacceptable toxicities caused by our product candidates could cause us or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA, the EMA or comparable regulatory authorities. Results of our trials could reveal a high and unacceptable severity and prevalence of side effects.

If unacceptable side effects arise in the development of our product candidates, we, the FDA, competent authorities of European Union member states, ethics committees, the institutional review boards, or IRBs, at the institutions in which our studies are conducted, or the Data Safety Monitoring Board, or DSMB, could suspend or terminate our clinical trials.

The FDA or comparable regulatory authorities could also order us to cease clinical trials or deny approval of our product candidates for any or all targeted indications.

Treatment-related side effects could also affect patient recruitment or the ability of enrolled patients to complete any of our clinical trials or result in potential product liability claims. In addition, these side effects may not be appropriately recognized or managed by the treating medical staff.

We expect to have to train medical personnel using our product candidates to understand the side effect profiles for our clinical trials and upon any commercialization of any of our product candidates.

Inadequate training in recognizing or managing the potential side effects of our product candidates could result in patient injury or death.

Any of these occurrences may harm our business, financial condition and prospects significantly.

>>12143900

>The DS needs the vaccine to fail in order to decimate global economies for GREAT RESET

Define fail.

If no one takes it, that's a fail, but one that they don't want. They want that people accept getting a shot every few months, like the sheep they are.

Their goal is not just the reset, but also mass genocide.

Let's say tons of people take it, and it does something to them. MSM will simply invent COVID-21 and blame everything on it, instead of blaming the vaccine. That's how the game is supposed to work. Always blame something or somebody else. That would also be fail, in a sane that the vaccine is supposed to help, but doesn't.

Or of course the plot could also be:

Tell people to get the shot.

Vaccine-deniers say the opposite.

The shot actually helps in a way this time.

Now the vaccine-deniers can be called enemies of the people.

That's why I am very careful when I say things. I don't claim to know that the vaccine is bad. I simply say "the UK government released a doc saying that it is unknown if the vaccine has any effect on fertility"

I don't run around say "it will make you sterile", because I don't know and it could be the case that they want people to do that to then turn it around and blame the ones saying bad things about their glorious vaccine.

When I say the truth, the worst that could happen is that nothing happens. When something does indeed happen, I can say "well, I told you that there is a risk involved and it wasn't tested properly". I can not attacked that way for the things I stated.

>>12144012

>here is a non age restricted version

Replace youtube.com with invidio.us to avoid getting age restriction login.

>>12144120

Look up "Ailice in Wonderland", Japan independent release.

https://soundcloud.com/halcyon-bird/ailice-in-wonderland-01-fractal-demo

Really awesome music on there.

I can upload MP3s, if you want me to.

>>12144238

Do you want to participate in potentially mass genocide?

Is mass genocide okay, when you do not like the people who are getting killed?

>>12144256

>No, it isn't. We must help them.

Exactly.

>>12144262

>and just use the word 'murder'

Okay, so mass murder it is, or let's call it "murder". Whatever.

When you believe atm that according to your information the vaxx will be deadly/may sterilize the people taking it, and you WANT some people that you do not like to take it (for example niggers), what does that make you?

I want no one to take it, not even antifa-scum. At the same time I respect free will and I could also be wrong, so what I can do is to provide information and people choose for themselves.

>>12144289

>gene therapy to build babies that aren't degenerate

What do you mean?

How about stopping poisoning food, water, air and so on?

Instead of going "problem, reaction, solution" like they do with the aluminium chemtrails for decades now, making plants + other lifeforms sick, and then present the solution - special plants that are resistant to the poison, that you need to buy from certain companies, which also means in the end full control over food supply.

Same shit may or may not be happening here.

You want babies that are not sick/malformed?

Buy this gene therapy from us, we don't know what causes all these problems, it's weird, but somehow we found the solution to it and sell it to you.

>remove defective people from our midst

Deep State Virus

>>12144379

>Genetic mutations cannot be fixed.

Oh wow, who told you that? One of these "medical doctors"?

Do you also "know" that these so called auto immune diseases can not be fixed?

And that somehow no one knows what causes them?

But that vaccines are definitely not responsible for these auto immune diseases (except for that rushed vaccine in 2009)?

>>12144454

>Because I know from first-hand experience.

So you are one of these "medical doctors"?

How do you actually KNOW?

>>12144469

Okay, so you went to doctors and they told you something.

Why the fuck would you believe these people?

To me they said I would lose my colon, and that was over 11 years ago. My colon is still with me. No chemo therapy shit. Without my own research, I may even be dead by now.

Go to your doctors and ask them about vaccines. Ask them about MRC-5 and WI-38, if they know what that is, right after asking them if vaccines are safe.

I'm pretty sure they will tell you that vaccines are indeed safe, but will then tell you that they don't know about MRC-5.

Medical doctors are most of the time like programmed robots.