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The Impossibility of FDA Approval for Clonal Antibodies
Some of the hurdles that FDA requires of companies is are impossible to make, even though it's so obviously safe. I'm confident it's true that these test tube studies do correlate with clinical benefit, but you should apply it consistently across the agency because it's sort of a law of biology, if you like. The vaccine side of FDA's house actually is using that construct to get new versions of the vaccine on the market.