Replies to post #155737 on NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

Their lawsuit was dismissed. Effectively they could not make their claim directly in the suit or their counsel would have been sanctioned by the court. But their lengthy complaint effectively restated this claim over and over again via different columns of AF and in different ways, and that the co., did not inform their investors of these facts. And, again, the court standard of proof pre-trial is the LOWEST standard of proof in court, just a scintilla of evidence to suggest there might be a valid controversy to investigate and litigate. The plaintiffs could not meet that standard and the case was dismissed, allowing them to re-file in a set time if they had mad a mistake. They did not re-file!!! Because they had no case!! They relitigate this in blogs, Twitter and bulletin boards because there are no evidentiary standards to be met for such forums.

[marzan]

kabu et al., how could the shorties justify this: if the trial failed due to PFS in 2015, how can anyone prolong this trial with the same progressed patients this long to 2018. We have 90+ patients still living and are surviving almost two full years past 2015.

[VuBru]

Just spitballing here - Maybe the interim analysis was done at the originally planned time. I think it is certainly plausible that PFS appeared to have "failed," maybe related to the difficulty of accurately identifying pseudoprogression using their original study protocol. Maybe it even looked like DCVAX was making progressions occur faster than in SOC alone. This could make the FDA say, "you need to stop enrolling because the patients might be harmed by the treatment." The company could come back and say "it may look that way but here are some data indicating that this is not real progression. In fact, our patients appear to be living much longer. We think the drug is having significant clinical benefits." After some back and forth, eventually the company convinces the FDA that their arguments are valid, and the FDA lifted the hold because no new patients would be exposed to the treatment, so there was no added patient risk. The company then decided to continue the study as long as possible to maximize the OS data (going beyond the minimum target), knowing that PFS may look bad (but for explainable reasons). They would have even greater incentive to do so given the apparent FDA changes planned for these types of immunotherapies, particularly given that this is an orphan indication. The publication describing blinded OS data indicating that patients are living much longer than expected compared to a variety of SOC data sources then comes out. Everyone begins to realize that the treatment actually works in terms of increased survival. The rest is (future) history.