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exwannabe

07/16/24 12:45 PM

#706421 RE: dennisdave #706418

It is not complicated.

Individual patient level data means that the specific data for each patient is in the dataset submitted, not just average or groupings. NWBO does not have that, and the FDA expects it.

That you and senti keep saying it would be impossible to have trials if individual patient level data was required is nonsense as it is being done now.