My understanding is FDA does have the authority to access patient level data and that it is up to them to keep it confidential when accessed. However, even if FDA does not have generally open access to past patient level data and that data is kept confidential when they do have access during a trial then in that scenario comparing patient level data becomes impossible because a blinded data base has not been made readily available. NWBO can offer patient level data but without any patient level data to compare to there is no point at all in doing so. Anyone who wishes to speak out against the NWBO ECAs can suggest that the comparator sponsors of studies used for the ECAs offer their patient level data to FDA under a confidentiality agreement if they want to and then FDA can match to L trial patients with blinded identifiers so that a comparison that way can be made. I doubt anyone is going to go to this trouble even if they could when no one can find anything truly wrong with the ECAs as compiled except to claim them as weak with no proof they are. Most would agree that FUD does not count as proof; ). Best wishes.
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