Let's say your conditional approval scenario happens. Then kids get the drug and results speak for themselves but MSB doesn't end up doing the RCT within 2 years (or whatever agreed timeframe). FDA are then faced with the decision on full approval with even more data on the drug in market but they still don't have the RCT.... The FDA have shown a number of times in recent years leniency on their own processes and preferred trial methods, particularly with new therapies, because they have reasonable reason to do so. A conditional approval would be a bit of a furfy IMO.
2023 The Final Countdown, page-2767
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