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#54391 | |
TACO SALAD
Join Date: Apr 2008
Location: yes
Casino cash: $-2001532
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Quote:
I don't know why mRNA would not be considered a vaccine. I think both the Johnson & Johnson and Astrazeneca vaccines are live virus DNA type vaccines if you'd prefer. |
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Posts: 7,067
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#54392 |
Life is changing..
Join Date: Jul 2012
Location: NW Missouri
Casino cash: $-2490000
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Posts: 43,082
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#54393 |
Life is changing..
Join Date: Jul 2012
Location: NW Missouri
Casino cash: $-2490000
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Posts: 43,082
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#54394 |
Generational Player
Join Date: May 2017
Location: Honolulu
Casino cash: $430400
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Both Pfizer and Moderna stated the FDA position in their SEC filings:
"Currently, mRNA is considered a gene therapy product by the FDA. Unlike certain gene therapies that irreversibly alter cell DNA and could act as a source of side effects,... https://www.sec.gov/Archives/edgar/d...a-20200630.htm |
Posts: 10,038
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#54395 |
Life is changing..
Join Date: Jul 2012
Location: NW Missouri
Casino cash: $-2490000
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Posts: 43,082
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#54396 |
MVP
Join Date: Oct 2012
Location: Lenexa, KS
Casino cash: $1536717
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I'll admit I am very frustrated at this point and prone to lashing out. I know I am not helping, but damn I can't help replay in my head how this should be done and buried, but a lot of Americans of different stripes aren't doing what it takes.
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Posts: 14,411
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#54397 | |
MVP
Join Date: Oct 2017
Casino cash: $-89600
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Quote:
Gene therapy product. Not gene therapy. I don’t really like the confusing language of this claim by Moderna. Gene therapy alters dna in the cell nucleus. The vaccine does not. Gene therapy can create mRNA, but an mRNA vaccine isn’t gene therapy. The product does not even enter the nucleus of the cell. |
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Posts: 7,388
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#54398 | |
Generational Player
Join Date: May 2017
Location: Honolulu
Casino cash: $430400
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Quote:
More in document: 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 are 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 investigational medicines and gene therapies, the classification of some of our mRNA investigational medicines as gene therapies in the United States, the European Union, and potentially other countries could adversely impact our ability to develop our investigational medicines, 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 investigational medicines irrespective of the mechanistic differences between gene therapies and mRNA. Adverse events reported with respect to gene therapies or genome editing therapies could adversely impact one or more of our programs. Although our mRNA development candidates and investigational medicines are designed not to make any permanent changes to cell DNA, regulatory agencies or others could believe that adverse effects of gene therapies products caused by introducing new DNA and irreversibly changing the DNA in a cell could also be a risk for our mRNA investigational therapies, and as a result may delay one or more of our trials or impose additional testing for long-term side effects. Any new requirements and guidelines promulgated by regulatory review agencies may have a negative effect on our business by lengthening the regulatory review process |
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Posts: 10,038
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#54399 |
Cheat Death
Join Date: Nov 2007
Location: Land of Drincoln
Casino cash: $-1521756
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Here in Chicago we went from a high average of 30K shots per day in late April to around 4K per day steady in July into August, sitting close to 60% fully vaxxed citywide.
It just seems like its a slow trickle, is what it is type of situation here until something happens to generate more motivation. |
Posts: 36,935
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#54400 | |
MVP
Join Date: Oct 2017
Casino cash: $-89600
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Quote:
Heck. Continue reading what you posted ****************** 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 investigational medicines irrespective of the mechanistic differences between gene therapies and mRNA. |
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Posts: 7,388
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#54401 | |
Generational Player
Join Date: May 2017
Location: Honolulu
Casino cash: $430400
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Quote:
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Posts: 10,038
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#54402 | |
MVP
Join Date: Oct 2017
Casino cash: $-89600
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Quote:
It is a vaccine. It doesn’t alter your genetics or DNA. Any claim you make that tries to negate these truths is subterfuge. Last edited by SupDock; 08-08-2021 at 09:04 AM.. |
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Posts: 7,388
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#54403 |
Stay positive, don't give up
Join Date: Dec 2001
Casino cash: $1739383
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I'm not liking more and more news of kids getting really sick now and being hospitalized.
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Posts: 46,296
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#54404 | |
Hey Loochy, I'm hooome!
Join Date: Oct 2008
Location: PooPooKaKaPeePeeShire
Casino cash: $-1649603
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Quote:
Then more kids will get sick And more will be hospitalized Get used to it, because you can't do anything about it other than hide in a hole and not send kids to school
__________________
Hey Loochy, I'm hoooome! ![]() |
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Posts: 42,116
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#54405 | |
Generational Player
Join Date: May 2017
Location: Honolulu
Casino cash: $430400
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Quote:
Truth can be changed with $$$$, see the change in the definition of the scientific term "herd immunity" that took place at the World Health Organization where people who had Covid, recovered, and were now immune are not counted as immune. Don't worry, if these companies want to get their products labeled a certain way, they will get their way. |
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Posts: 10,038
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