Sorry, after 20+ years in biopharma world, have a pretty good understanding. Sing and dance all you want, but NWBO's near post hoc trial revisions violate numerous FDA Guidelines. And FDA ain't buying what you are selling. NWBO meet with FDA and reviewed the data and what did NWBO do NOT FILE WITH THE FDA!!!! Why? FDA said the P3 trial did not meet FDA requirements for commercial review. So NWBO filed with the UK NOT THE FDA.
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