Many of your points are spot on. The one company that has passed go in the game of antibody testing monopoly is an obscure private Company. Are you able to get the statistical trial data including where and how the trials were run? That might be worth mirroring to save time and add credibility. The FDA is the FDA, for good or bad, and they embarked on a slippery slope during a panic week allowing companies to submit their own clinical data. As the curve flattens they may be slow walking following through with that. I don't understand your test at all, as serology tests require a reagent additive. If the accuracy data of GenViro is verified the FDA will be hard-pressed not to put it in the winner's circle.
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