Tuesday, July 16, 2024 12:36:50 PM
That is not what individual patient level data means.
Its you who don't understand what individual patient data means and why its not necessary for ECA comparison.
Why are you convinced LL is an idiot when she bemoans
Looks to me like plenty of cancer trials are being run and we have yet to see one with an approval based on summary level ECA data.
Provide me with a current lethal cancer medical trial where the sponsors have no problem letting the placebo group parish to be able to compare the data to the treatment arm. I know you are medieval and have no ethics but that is not how we do things anymore in 2024.
If it is so obvious that the concept makes no sense, then why did the FDA put it in their ECA guidance?,
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