From the 2030 UnMasked Documentary, see this clip (timestamps of 49 mins 26s to 50 mins 37s in the full documentary).
It refers to the Bio-N-Tech SEC filing (this is the current version online, or, see the PDF here, and/or here), which states:
Although we expect to submit BLAs for our mRNA-based product candidates in the United States, and in the European Union, mRNA therapies have been classified as gene therapy medicinal products, other jurisdictions may consider our mRNA-based product candidates to be new drugs, not biologics or gene therapy medicinal products, and require different marketing applications.
Also in the document, though, not highlighted by the documentary (found this while trying to confirm the above source for the documentary):
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.
In regards to your comment:
I don't know why people care so much about changing biology to force the vaccine to be a gene editing system. There is so much wrong with the vaccine. We don't need to create more problems with it by attempting to change the evidence to fit our desires for additional fuckery.
I agree, there is plenty wrong with the mRNA-jabs.
Regardless of whether they do "alter your DNA (permanently)".
If it does though, then that's good to know.
And if not, then that's also good to know (to be more based in reality, and avoid spreading bad information).
With the above in mind, I would edit my thread title if I could, to leave more room for 'doubt' about what this means. I'll leave it be as is now though, to give people the opportunity to read these comments & add any additional information.
From the 2030 UnMasked Documentary, see this clip (timestamps of 49 mins 26s to 50 mins 37s in the full documentary).
It refers to the Bio-N-Tech SEC filing (this is the current version online, or, see the PDF here, and/or here), which states:
Although we expect to submit BLAs for our mRNA-based product candidates in the United States, and in the European Union, mRNA therapies have been classified as gene therapy medicinal products, other jurisdictions may consider our mRNA-based product candidates to be new drugs, not biologics or gene therapy medicinal products, and require different marketing applications.
Also in the document, though, not highlighted by the documentary (found this while trying to confirm the above source for the documentary):
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.
In regards to your comment:
I don't know why people care so much about changing biology to force the vaccine to be a gene editing system. There is so much wrong with the vaccine. We don't need to create more problems with it by attempting to change the evidence to fit our desires for additional fuckery.
I agree, there is plenty wrong with the mRNA-jabs.
Regardless of whether they do "alter your DNA (permanently)".
If it does though, then that's good to know.
And if not, then that's also good to know (to be more based in reality, and avoid spreading bad information).
With the above in mind, I would edit my thread title if I could, to leave more room for 'doubt' about what this means. I'll leave it be as is now though, to give people the opportunity to read these comments & add any additional information.
From the 2030 UnMasked Documentary, see this clip (timestamps of 49 mins 26s to 50 mins 37s in the full documentary).
It refers to the Bio-N-Tech SEC filing (this is the current version online, or, see the PDF here, and/or here), which states:
Although we expect to submit BLAs for our mRNA-based product candidates in the United States, and in the European Union, mRNA therapies have been classified as gene therapy medicinal products, other jurisdictions may consider our mRNA-based product candidates to be new drugs, not biologics or gene therapy medicinal products, and require different marketing applications.
Also in the document, though, not highlighted by the documentary (found this while trying to confirm the above source for the documentary):
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.
In regards to your comment:
I don't know why people care so much about changing biology to force the vaccine to be a gene editing system. There is so much wrong with the vaccine. We don't need to create more problems with it by attempting to change the evidence to fit our desires for additional fuckery.
I agree, there is plenty wrong with the mRNA-jabs.
Regardless of whether they do "alter your DNA (permanently)".
If it does though, then that's good to know.
And if not, then that's also good to know (to be more based in reality, and avoid spreading bad information).
With the above in mind, I would edit my thread title if I could, to leave more room for 'doubt' about what this means. I'll leave it be as is now though, to give people the opportunity to read these comments & add any additional information.
From the 2030 UnMasked Documentary, see this clip (timestamps of 49 mins 26s to 50 mins 37s in the full documentary).
It refers to the Bio-N-Tech SEC filing (this is the current version online, or, see the PDF here, and/or here), which states:
Although we expect to submit BLAs for our mRNA-based product candidates in the United States, and in the European Union, mRNA therapies have been classified as gene therapy medicinal products, other jurisdictions may consider our mRNA-based product candidates to be new drugs, not biologics or gene therapy medicinal products, and require different marketing applications.
Also in the document, though, not highlighted by the documentary (found this while trying to confirm the above source for the documentary):
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.
In regards to your comment:
I don't know why people care so much about changing biology to force the vaccine to be a gene editing system. There is so much wrong with the vaccine. We don't need to create more problems with it by attempting to change the evidence to fit our desires for additional fuckery.
I agree, there is plenty wrong with the mRNA-jabs.
Regardless of whether they do "alter your DNA (permanently)".
If it does though, then that's good to know.
And if not, then that's also good to know (to be more based in reality, and avoid spreading bad information).
From the 2030 UnMasked Documentary, see this clip (timestamps of 49 mins 26s to 50 mins 37s in the full documentary).
It refers to the Bio-N-Tech SEC filing (this is the current version online, or, see the PDF here, and/or here), which states:
Although we expect to submit BLAs for our mRNA-based product candidates in the United States, and in the European Union, mRNA therapies have been classified as gene therapy medicinal products, other jurisdictions may consider our mRNA-based product candidates to be new drugs, not biologics or gene therapy medicinal products, and require different marketing applications.
Also in the document, though, not highlighted by the documentary (found this while trying to confirm the above source for the documentary):
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.
In regards to your comment:
I don't know why people care so much about changing biology to force the vaccine to be a gene editing system. There is so much wrong with the vaccine. We don't need to create more problems with it by attempting to change the evidence to fit our desires for additional fuckery.
I agree, there is plenty wrong with the mRNA-jabs.
Regardless of whether they do "alter your DNA (permanently)".
If it does though, then that's good to know.
And if not, then that's also good to know (to avoid spreading bad information).
From the 2030 UnMasked Documentary, see this clip (timestamps of 49 mins 26s to 50 mins 37s in the full documentary).
It refers to the Bio-N-Tech SEC filing (this is the current version online, or, see the PDF here, and/or here), which states:
Although we expect to submit BLAs for our mRNA-based product candidates in the United States, and in the European Union, mRNA therapies have been classified as gene therapy medicinal products, other jurisdictions may consider our mRNA-based product candidates to be new drugs, not biologics or gene therapy medicinal products, and require different marketing applications.
Also in the document, though, not highlighted by the documentary (found this while trying to confirm the above source for the documentary):
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.
From the 2030 UnMasked Documentary, see this clip (timestamps of 49 mins 26s to 50 mins 37s in the full documentary).
It refers to the Bio-N-Tech SEC filing (this is the current version online, or, see the PDF here, and/or here), which states:
Although we expect to submit BLAs for our mRNA-based product candidates in the United States, and in the European Union, mRNA therapies have been classified as gene therapy medicinal products, other jurisdictions may consider our mRNA-based product candidates to be new drugs, not biologics or gene therapy medicinal products, and require different marketing applications.
Also in the document, though, not highlighted by the documentary:
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.
From the 2030 UnMasked Documentary, see this clip (timestamps of 49 mins 26s to 50 mins 37s in the full documentary).
It refers to the Bio-N-Tech SEC filing (this is the current version online, or, see the PDF here, and/or here), which states:
Although we expect to submit BLAs for our mRNA-based product candidates in the United States, and in the European Union, mRNA therapies have been classified as gene therapy medicinal products, other jurisdictions may consider our mRNA-based product candidates to be new drugs, not biologics or gene therapy medicinal products, and require different marketing applications.