"Simply repeating the trial without the new 1,2,4 year data or the new potency data was never going to lead to approval"
Well you are right, but then again that wasn't what the FDA asked for
On the other hand, completing a successful RCT in adults to prove that the all new manufacturing method had in fact increased potency and all the relevant data including biomarkers had been collected and correlated with the mechanism of action would have led to approval.
2023 The Final Countdown, page-2697
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