Shorts such exwannebe are trying to claim that in order to build an ECA comparison the sponsor (NWBO) would need individual patient data (such as health status, age, lifestyle background gender etc etc). The mentioned shorts then go on to claim that this type of patient-level data is required by the FDA which is a false statement. I quoted what the FDA requires in order to provide an ECA that the FDA would accept.
Senti - regarding sharing of patient level data, is this standard behavior among companies? Wouldn’t they be motivated to share the data, as presumably it would show patient differences that would weaken NWBios results?
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