Replies to post #424418 on NorthWest Biotherapeutics Inc (NWBO)

[HappyLibrarian]

As mentioned in Chapter 3, 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. However, a 2012 study found that the results of 30 percent of 400 clinical trials had neither been published nor reported on ClinicalTrials.gov 4 years after study completion (Saito and Gill, 2014).

https://www.ncbi.nlm.nih.gov/books/NBK286004/

An Act is the law, not regulatory guidance.

The fact that regulators have done a poor job of enforcing the law does not make breaking the law okay or eliminate the ability of shareholders to take legal action if failure to follow the law resulted in losses. Maybe NWBO can argue in court that failing to abide by the law is the 'industry standard.' I am sure the judge will be amused and just grant them another dismissal for 'failure to state a claim.'