Oh thanks, I missed/ forgot about this PR. I thoug
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Posted On: 01/25/2022 7:35:35 AM
Oh thanks, I missed/ forgot about this PR. I thought this was just mentioned in one of the last CCs. Did Nader not talk about the possibility of meta analysis also with ANVISA? Or was this just with US FDA?
Just some wild guesses:
1. We had 5 critical patients by mid of January;
2. I assume a conservative enrollment rate of 5 critical patients/ week (21 ICUs !) starting by mid of January;
=> we could have full enrolled by end of March for interim (with some tailwind)
=> interim analysis could start at the mid/end of April
With 10 critical patients/ week we would start interim analysis in mid of march.
With stellar results and if ANVISA agrees on a meta analysis with the 62 critically ill patients in the CD12 trial we could have some serious base ground for an EUA.
Just some wild guesses:
1. We had 5 critical patients by mid of January;
2. I assume a conservative enrollment rate of 5 critical patients/ week (21 ICUs !) starting by mid of January;
=> we could have full enrolled by end of March for interim (with some tailwind)
=> interim analysis could start at the mid/end of April
With 10 critical patients/ week we would start interim analysis in mid of march.
With stellar results and if ANVISA agrees on a meta analysis with the 62 critically ill patients in the CD12 trial we could have some serious base ground for an EUA.
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