NorthWest Biotherapeutics Inc (NWBO)

[Umibe5690]

Meirluc:

I agree with your analysis. It makes sense and is more positive than mine. If they have met the PFS endpoint of 4 months delta over control, then it would appear that they have the home runs required to obtain regulatory approvals in most, if not all, jurisdictions.

From the lack of transparency and nonsense responses Les has provided---e.g., not revealing the number of trial patients alive as of the latest update because NWBO could be accused of "cherry picking"---the perception created is that something is amiss with the trial. It may have to do with not achieving the required PFS delta. This is a primary end point and may be at risk. They don't know for sure but it is possible that their review thus far points in that direction. Thus, the strong emphasis on long tail and OS milestones. Not achieving the required PFS delta is by no means fatal. There are explanations. Possibly, PFS eventing may come earlier due to the fact that immunological approaches such as DC VAX become more established and entrenched over time and progression rates may slow dramatically thus resulting in longer OS. This is not bad but naysayers will turn "good news" into "bad" by harping on the failure to achieve the delta.

But once you are placed into a position where you need to provide an explanation for why you failed to achieve the desired end point, to "tell it to the judge" so to speak, your position is weaker. Sticklers may claim that you failed to achieve a primary endpoint, so do another trial IF you don't have strong countervailing data such as OS and the long tail. I think that running the trial as long as they have and are continuing to collect data as they work to data lock, etc. provides for an insurance policy. They have got to get it right the first time or we all go home. Thus everything is cloaked in secrecy until they are ready to come out with all the info and analysis as powerful ammunition to gain approval across the spectrum of RAs.

As I have said, I believe the odds are good that NWBO will gain approvals. To me, it is an issue of when and not necessarily if. Let's hope it is sooner.

More transparency would certainly give us more to work with in assessing the odds. And it would do something for the credibility of management. However, some of the answers provided strain credulity and insult the intelligence of investors. Not to mention the possible impact on the pps. JMHO.