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anders2211

06/23/21 6:17 AM

#385991 RE: ahp123 #385976

Well She/the company is already in Direct contradiction with alt of the rules of 42 CFR part 11, just look at this “ General Requirements (42 CFR Part 11)



I know they are to all of our frustration.

So if they have new endpoint it should be listed… but as everybody knows, Linda doesnt give a s… about rules…



I have never asserted that NWBO/LP is such a star in following the rules precisely and with great enthusiasm they don't. The late submission of 10Q comes to mind. By the way, the non-compliance of not submitting trial data is a much worse offense than not updating ClinicalTrials.gov with the primary Completion Date within 30 days.