The goal posts never moved. They told Mesoblast to do another randomised, controlled trial in 2020 as there were numerous shortcomings in the original trial/s relied upon in the original application. For whatever reason, your management decided they could continue slicing and dicing the original trial data to create what the FDA wanted, which was ignorant at best, but a more appropriate description would be negligent. Three years and over $100M dollars later, the FDA still want a randomised, controlled trial.
The FDA is a corrupt organization., page-20
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