For those who say, quite often, you must run an RCT , blah blah blah - the link will take you to hundreds of examples of accelerated approvals based on merely a surrogate endpoint . (CDER table)
"No no - it can't be so - you have to run RCT's - I have said so many hundreds of times "
pity the bureaucrats havent used real world survival data
https://www.fda.gov/media/151146/download
Efficacy for pediatric SR aGvHD is proven. It hit its primary endpoint.
Potency assay data work on the 001 trial to be presented or has been presented.
Would the board bother to present if they did not have the correct data? They would look extremely foolish if that occurred.
Big chance for pediatric full approval/ accelerated approval - safety and efficacy not an issue.
Reg
AA, page-3
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