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07/18/24 7:12 PM

#706934 RE: learningcurve2020 #706931

learningcurve2020,

Already told you. THEY changed the clinical trials site. THEY don’t do that unless THEY approve. FDA does NOT update clinical trials site. That is the responsibility of the sponsor which is why NWBO did NOT update the site until after the SAP had been publicly presented at a scientific conference to prevent potential legal challenges which is why the coordinated bear raid came. The nuances in the guidance regarding changes along the lines of exceptions to adequate and well controlled studies created this scenario. I have shared this numerous times over the years. Best wishes.