Replies to post #375228 on NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

The entire discussion is nonsense at this point. This is a reg/rule that is intended to encourage behavior. It is not something that any regulatory agency at this moment is charged with enforcing and for which there is no strict enforcement. One of the reasons for that is that the FDA views this process as CONFIDENTIAL, and there are securities laws as well that might be disturbed by aggressive use of this “rule”. So there is an incredible degree of deference to the relevant companies and trial managers as to when or how these are updated.

No one is going to force them or penalize them.

This was discussed last year. ExW took an absolutist approach that the lack of updates was a fraud. He thought the NIH was under FDA, and that they were an enforcement agency. When I cleared all of the confusion that he wrought about that, he went quiet for a year or so... and now, just like all the fud these guys throw at the wall constantly, it is back again.

[anders2211]

Sorry for late response 10b I used my 15 posts yesterday

Just so I’m clear, are you saying that you agree that the Primary Completion Date should technically be updated within 30 days of completion, but that there are no significant penalties for failing to do so?

I agree that updating the government website is mandatory 30 days after completion of the study. I am trying to base my view on all NWBO related matters as much as possible on facts and not opinions of posters here. Facts to me are reliable sources of third parties outside Ihub. I have not seen one link/quote to/from a reliable source saying that violating any FDA rules does not have consequences/not being enforced.

When I read this from the government website:

42 CFR 11.66 describes the potential legal consequences for responsible parties if they do not comply with the requirements to submit registration and results information on applicable clinical trials. Such potential legal consequences include civil or criminal judicial actions, civil monetary penalty actions, and grant funding actions

then logically one can only hold the view that violating the mandatory study results can have severe consequences. The FDA keeps reminding biotechs that not updating the study completion 12 months after can have severe consequences much more than the 30 days, see above and also this:

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

These consequences can also affect Dr Liau, I can't imagine NWBO throwing her under the bus like that.

Anyway, I have not seen a link to a reliable source where it says that not updating completion 30 days after has NO consequences thus I assume it has consequences but again not nearly as not providing study results.