Replies to post #375192 on NorthWest Biotherapeutics Inc (NWBO)

[anders2211]

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 of study completion

I have many already pointed you to your responsibility to quote a source if you claim anything

but must update the status to "complete" within 30 calendar days of the trial reaching completion. They have never done that.

Please link me to a source where the FDA requires biotechs to update the status to "complete" as you claim.

In any case, the FDA rule does not require that, so now you are just making stuff up.

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 of study completion

point me to the FDA text where says
A. you must first update ClinicalTrials.gov with "complete" as you claim
B. NWBO has Pred the completion of the trial on July 24 2020 which is by definition of the




https://www.prnewswire.com/news-releases/northwest-biotherapeutics-announces-completion-of-phase-3-trial-sites-databases-301099438.html

[OilPatch]

TBH LP would have sufficed, no need to use nationality/race as the identifier, completely unnecessary.

[anders2211]

Now you are starting to make things up !! again..
I have already pointed you to your responsibility a few times to quote a source if you claim anything

but must update the status to "complete" within 30 calendar days of the trial reaching completion. They have never done that.

Please link me to a source where the FDA requires biotechs to update the status to "study complete" as you claim before the 12 months time clock starts ticking.

In any case, the FDA rule does not require what you claim if you take the trouble to actually read the FDA rule, so now you are just making stuff up.

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 of study completion

point me to the FDA text where it says
A. you must first update ClinicalTrials.gov with "complete" as you claim and then the 12 months start to count down.
B. NWBO has Pred the completion of the trial on July 24 2020 which is by definition of the FDA rule the completion date of the trial, again NO completion first update is required in ClinicalTrials.gov according to the rule as quoted
https://www.prnewswire.com/news-releases/northwest-biotherapeutics-announces-completion-of-phase-3-trial-sites-databases-301099438.html