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[–] 8 points 9 months ago* (1 child)

Moderna noted that neither the FDA’s regulation nor its guidance to industry makes any reference to a requirement of the “best-available standard of care” in comparators.

But shouldn't they at least pretend that the new drug is better than the currently available options? Otherwise what's the point of making it?

edit: It's like Intel comparing their new CPUs with their last generation instead of what their competitors offer today.

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  • [–] 3 points 9 months ago

    It's about knowing your audience and phrasing things in a way to increase the likelihood of acceptance. So despite the FDA reviewing and accepting the trial design in April '24 and August '25, plus the trial demonstrating the vaccine to be more effective than the currently available vaccines, I'd bet my last dollar they phrased it like this just for RFK and friends...

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