At the end of the day, all of this is in vitro assays being applied retrospectively to existing data.
Which is great for hypothesis generation, IE:
- these biomarker levels can be used to evaluate batch potency
or another
- the level of biomarker X being greater than N in a batch will confer significant therapeutic efficacy when treating xyz
But you need to test those hypotheses. They will need another trial. It's the only way it makes sense to me. But again, we only know a select few pieces of the puzzle, so I could be missing something.
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