NorthWest Biotherapeutics Inc (NWBO)

[sentiment_stocks]

The odds of them failing their primary and secondary endpoints are practically nil... especially with regards to the primary.

They are comparing their treatment arm... which we know that as of October 2018 had at least one hundred patients of 331, so 30%, with a KM derived median OS of 58.4 months. Given that there are likely to be very few IDH-mutated patients in this trial (and there are studies showing them with medians of, at times, 35 months, give or take), and that most of these patients are likely IDH wild-type (the worst)... to the control arms from other trials who, as Linda Liau has herself indicated, had a median OS of around 17 months.

And then when we take the KM curve from the trial for BOTH the control and treatment patients displayed in the 2018 TMJ publication (with data from March 2017 that went to 36 months), it beats the KM curves for all the other trial control quite solidly. When you pull the treatment patients out, who very likely lived longer because they received DCVax-L earlier, on average, than those that received DCVax later, it's pretty much a given that their KM curve will reflect an even more impressive curve.

Finally, had the trial failed the primary endpoint, the company would have had to share that information with us... if not within four days of data lock, at least within a reasonable period of time after the data had been revealed to the principal insiders... unless, of course, you think they are crooks, and that the multitudes of lawyers intimately familiar with SEC laws advising them in order to prevent any new lawsuits from arising (after the plethora of frivolous ones they've had to contend with over the years) are all either stupid, or crooks as well.

So from my vantage, it's pretty much a no-brainer that they will present statistically significant data for the primary endpoint.

The hurdle they will face is that after the journal publishes the data, and explains it in a fairly extensive manner as to why they chose to compare the treatment arm to the recent trial controls (and FDA's OCE Richard Pazdur gave a pretty solid explanation of why they would as well back in October 2020 - click https://investorshub.advfn.com/boards/read_msg.aspx?message_id=165536943" rel="nofollow" target="_blank" >https://investorshub.advfn.com/boards/read_msg.aspx?message_id=165536943[taghere[/tag] to read his exact words), is that the bears will claim that they knew the data before data lock (despite having claimed in more than ten Qs and Ks that they were blinded; and having multiple advisors on their steering committee and scientific advisory boards who would have known otherwise) and therefore cheated in changing the endpoints. Finally these bears will try to convince a fairly neutral market that the FDA and the other regulatory agencies will not approve DCVax-L for these reasons, despite any stellar p values and hazard ratios. So the question is, will the market believe them?

Me thinks not... but, so that's what you've got to ask yourself, do you feel lucky?
If so, I wouldn't sell much at $4. If you don't feel so lucky, then sell.

Thing is, I feel lucky, so we'll see.