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Vincent Cifello's avatar

“Permanently changing the DNA” is not a necessary criterion for calling something “gene therapy”

Please see FDA guidance white paper for industry and Moderna/Pfizer SEC filings.

What’s next? It modified your DNA, but that wasn’t the purpose and so do other chemicals, so it’s not gene therapy unless all drugs are?

Don’t fall for it. Injecting modified genetic material to evade immune destruction and hijacking the gene transcription machinery IS gene therapy. Period.

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Vincent Cifello's avatar

https://www.fda.gov/media/113760/download

“ FDA generally considers human gene therapy products to include all products that mediate their effects by transcription or translation of transferred genetic material or by specifically altering host (human) genetic sequences.”

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