The Pediatric Investigation Plan was approved in 2022 using the same matched external control methodology as the adult trial.
That argument is very flawed.
First, the pediatric studies are early stage, not pivotal. Nobody cares if the endpoint is established, it just needs to be sufficient to run later stage trials. Many such trials have similar OS comps.
Second, he fact that it is prespecified is a huge factor. Read the MHRA guidance and see how often they talk about pre-specified. And they define that as prior to enrollment. IMO , that is a bigger problem with the -L trial analysis than lack of patient level data..
Third, though it uses an ECA, it is not the exact same SAP. That is obvious. That LP hypes it as the same is just playing to her suckers.
But whatever. LP played a brilliant card wasting time on submitting a PIP that is never going to be used. Plenty of free hype.
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