Accelerated approval comes based on surrogate endpoints.
Where do those come from?
Either a new trial that is powered to assess the surrogate endpoints or what you suggest, the old trial that failed to meet the primary endpoints and only through subgroup analysis did they find significance, though these were findings that make no sense.
You think the FDA is going to allow an intracardiac injection of experimental cells to go to market based on a failed trial without the need for a well designed trial with the aim to cease early based on surrogate markers?
Guess we will see, hey?
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