Replies to post #424414 on NorthWest Biotherapeutics Inc (NWBO)

[HappyLibrarian]

The citation is in here:

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

[exwannabe]

citation for the 12 months to release TLD? I’ve seen that thrown around but never seen it backed up

Go to clincaltrials.gov (the registry created by the regs in question) and dig through the material on the subject.

There is such a rule, but there also exceptions. Also, the rule is frequently violated.

Reality is that small institutional trials are often very late or never reporting. Failed commercial trials are also problems.

Positive P3 commercial trials report fast though. It is in the companies financial interest to do so.

Positive TLD is better advertising than a tote bag.

[hoffmann6383]

There is a law that you are supposed to release the data within 12 months. It is not enforced by the FDA. See:

https://www.science.org/content/article/fda-and-nih-let-clinical-trial-sponsors-keep-results-secret-and-break-law

On the other hand, I believe there is a law that you are supposed to release negative TLD within 5 days. I'm not sure if this one is enforced, I would guess not.

Bottom line, this 12 month rule that people throw around and the speculation that comes from it is nonsense. The rule is not enforced.

[FeMike]

FDA and NIH 2017 Protocol

a 2007 law made posting mandatory for many trials registered in the database. In 2017, the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) tried again, enacting a long-awaited "final rule" to clarify the law's expectations and penalties for failing to disclose trial results. The rule took full effect 2 years ago, on 18 January 2018, giving trial sponsors ample time to comply.....(sponsors) must deposit results and other data within 1 year of completing a trial

And from the actual final rule (Federal Register.gov)

this rule requires the submission of results information not later than 1 year after the completion date (referred to as the “primary completion date”) of the clinical trial, which is defined as the date of final data collection for the primary outcome measure.

So yes, the rule very much exists and is real.

[biosectinvestor]

The period can be extended on request, and I expect that won’t be a problem this year. FDA has sent enforcement notices to about 3 parties that were flagrant violators who had announced their results, received letters of warning even published results but did not put them into the NIH website in the manner they were supposed to do. It should be possible for those parties to comply. Those violators had already released, had warning letters and were beyond the extension possibility I believe. They had already announced results.

Many, many more flagrant violators still are out there, and I doubt NWBO is at the top of the list, especially not this year and not with the option of getting an extension.

Another drama, for bulletin board fodder.