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Here's an excellent, level headed, scholarly article about the state of the current batch of gene therapy shots with regard to formal, mainstream approval.

Author goes into how the placebo groups were completely destroyed and the blind-studies were completely un-blinded.

None of the trials were subject to biodistribution studies either, they hand waved that.

One hopes this means formal approval is a pipe-dream, but none of the old rules apply anymore, so who knows.
bmj.com/content/373/bmj.n1244

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