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)
• The responsible party for an applicable clinical trial (ACT) must:
– Register the ACT on ClinicalTrials.gov no later than 21 days after enrollment of the first participant;
– Update the ACT on ClinicalTrials.gov at least once every 12 months with some items requiring update within 15 or 30 days of a change (e.g., Recruitment Status, Primary Completion Date within 30 days)
– Submit summary results (including adverse event information) not later than 1 year after the trial’s Primary Completion Date, with delays allowed in some circumstances
So if they have new endpoint it should be listed… but as everybody knows, Linda doesnt give a s… about rules…