Ok so no quote + link where The FDA mandates biotechs to first update clinicaltrials.gov before the 12 months start counting down.
I know lawyers who work like you, the point the judge/their adversaries just to a bunch of rules and hope their point will be magically proven.
It is undeniable that NWBO has not updated clinicaltrials.gov which they should have. Im not denying that.
However in the eyes of the FDA not updating trial data one year after is, given the new punishment introduced in Jan 2018 by the FDA, not nearly as severe as neglecting simple administrative updates!
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