FDA did not say that either... they said they wanted MSB to produce further evidence of efficacy, and that is exactly what has occured - using the gold standard of efficacy proof. Survival.
FDA suggested an RCT as a way to gather said evidence, MSB found a much better way, that would otherwise have taken until 2025, and produced the same result.
Lucky MSB and industry are a step ahead of the FDA.... almost sounds like there was no input at all from the ethics department of FDA in the application. Zero.
2023 The Final Countdown, page-2641
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