Ha, Ha, MHRA approved the trial design for a FUTURE trial, not the P3 trial. The pediatric design required a prospective ECA (pre-trial), while the P3 trial was a post hoc ECA developed AFTER virtually all of the trial was complete. The P3 trial ECA used data derived from charts NOT patient level data, had poorly matched screener requirements among other significant differences.
Certainly no B.S. -- MHRA and FDA certainly know the difference.
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