Replies to post #375204 on NorthWest Biotherapeutics Inc (NWBO)

[anders2211]

(C) Primary Completion Date must be updated not later than 30 calendar days after the clinical trial reaches its actual primary completion date.

yes I did see that so? (and thanks for quoting better than point to 350 webpages). Still does not say that first the Primary Completion Date must be updated not later than 30 calendar days after the clinical trial reaches its actual primary completion date before the 12 months start counting.

If so this rule would have the following text
The Food and Drug Administration Amendments Act of 2007 (FDAAA) requires results of trials of FDA-regulated products to be reported to ClinicalTrials.gov within 12 months after ClinicalTrials.gov has been updated with study completion.

But it didn't say that.

and again which is my point the FDA did NOT mention any severe punishment when not updating the government site with simple administrative changes but since Jan 2018 DOES specifically and severely threatens with this

Failure to report the results of a clinical trial can distort the evidence base for clinical practice

when not updating 12 months after study completion which should scare the hell out of a biotech since it's the same FDA determining if a drug is approved yes or no.