Replies to post #375232 on NorthWest Biotherapeutics Inc (NWBO)

[CherryTree1]

FINALLY A BREATH OF FRESH AIR
This is the greatest exchange of crapola I have seen in a long time.
well at least since fart stains grapefruit juice enlightenments

[MI Dendream]

Biosect,

I think that I completely understand your point of view...if I can dumb it down for me to digest it is that the ‘enforcement’ of failing to provide investors with material information in a timely manner is the court system through law suits. Is this reasonably accurate?

Allow me ask a few questions that come at this from a different angle please. I do not know many of these answers and am legitimately asking although sometimes adding color.

Should a lawsuit be brought and won as to the question of failure to deliver in good faith, does LP carry any personal liability or is it solely the entity known as NWBO? How about if she were to strike financial deals like say an $11M loan with full knowledge of materially negative information that could easily bankrupt the company?

Would a response from FDA indicating that they will not accept the SAP as submitted or as they like to do sometimes ‘recommend’ that you run another trial be material? If Dr. Liau were to have a financial stake in any of these outcomes could she be liable for having this knowledge and continuing to promote DCVAX and/or the p3 trial design as viable? How about if she were to continue to treat patients with this knowledge instead of offering them approved alternatives and/or available research options?

Can a patient with a brain tumor provide reasonable consent to a therapy that is offered by someone or someplace that has a financial stake in that therapy if any of the above scenarios are true? Would an IRB let them? How about the attorney for that institution? Does NWBO have an obligation to update its investigators of any negative update about a research product immediately?

I can actually keep going on but I think these will suffice. The answers all come back to the ‘legality’ of withholding negative material information which I consider personal restitution to be similar enough to warrant no competent lawyer on Earth would allow. These families can go after individuals BTW. This I know.

[anders2211]

Provide a link + quote to and from a reliable resource where your opinion is based on ANY fact!

This is the FDA

Failure to report the results of a clinical trial can distort the evidence base for clinical practice, breaches researchers' ethical obligations to participants, and represents an important source of research waste. The Food and Drug Administration Amendments Act (FDAAA) of 2007 now requires sponsors of applicable trials to report their results directly onto ClinicalTrials.gov within 1 year of completion. The first trials covered by the Final Rule of this act became due to report results in January, 2018. In this cohort study, we set out to assess compliance

This is your opinion:

It is not something that any regulatory agency at this moment is charged with enforcing and for which there is no strict enforcement.

By the way, it was you who claimed that NWBO could only be fined with monetary penalties for not updating trial results 12 months after study completion the consequences are just a little harsher as you claimed, consequences are:

a. criminal judicial actions
b. civil monetary penalty actions
c. grant funding actions
d. Failure to report the results of a clinical trial can distort the evidence base for clinical practice

For not enforcing they sure have a lot of penalties!
NOT updating the trial results within 12 months after study completion is a criminal offense end of story

Only 10% of all burglaries are solved, does this now mean one has permission to break into a home? Even if the FDA does not act to uphold their own rules, which no one has proven here, then still that does not mean one can break FDA law, regs, or rules.