Correct, the MHRA explicitly approved the trial design and the fda also likely approved the design.
Nonsense.
The MHRA said in accepting the PIP that using pre-specified external controls in a single arm trial not designed for approval is reasonable for an early stage trial to advance the state of knowledge.
That is far different from saying implementing an ECA after a randomized trial failed the predefined endpoints is valid for establishing proof of efficacy.
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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