It has been a long time coming, but Northwest Biotherapeutics, Inc (OTCMKTS:NWBO) is finally starting to turn around. Longtime readers will know that this is one we have tracked closely over the last 18 months. The same readers will also know that, from a shareholder perspective, this has not been an easy stock to hold. A long time silence on the temporary halting of its lead trial led to wild speculation as to future prospects, and the company suffered considerably from a market capitalization perspective as a result.The last time we looked at this one, back on June 6, 2017, Northwest Biotherapeutics had just provided markets with an update as to the progress of the just mentioned phase 3 trial. The update served up some clarity as to what we could expect from a timeframe perspective, and highlighted July/August as a period to keep an eye on as a potential data-unblinding range.We are approaching this period, and the company is picking up strength as it goes. Chances are, markets are loading up in anticipation of positive results and the inevitable run (and dramatic influx of volume) that any such results would bring.So that's the big question – what are the chances of good results?Of course, it's not really possible to predict too accurately, since the data from the trial remains blinded. We can highlight the fact that it is ongoing, way beyond what we might expect in terms of survival for patients in this indication (glioblastoma multiforme, GBM) if they were just taking standard of care therapy, as indicative of strength, but that is a pretty loose conclusion and not one on which we could realistically base a directional thesis.There is something, however, that is of interest, and that management included as part of a recent presentation/update available here.On slide 16 of said update, the company included data from what it calls its Informational Arm, based on the survival of so-called Indeterminate Patients.Take a look at the image below.sourceThis image represents the 25 patients that comprised the Informational Arm, which was made up of patients not eligible to enroll in the primary trial due to radiographic evidence of rapid disease progression prior to the baseline screening visit – in other words, patients whose disease was progressing too fast. Northwest put them into an exploratory arm and gave them active drug.As the image shows, standard of care therapy generally translates to an overall survival rate of between 15 and 17 months (the gray column). 17 out of the 25 patients exceeded 17 months' overall survival. That's 68%. As annotated on the chart, 40% of patients have exceeded 35 months' overall survival. 24% of patients have exceeded 48 months' overall survival. Remember, these are rapid progression patients – those with what we might deem the more severe end of this already very deadly disease.If this is how the drug performed in these patients, then there's a strong chance that we could see similar positive results from the primary study as and when it hits press. Of course, this is speculative, and these data are only guidelines numbers – the sample size is small and this isn’t the ITT population. With that said, however, it's pretty much all we have in terms of informational insight, and it looks strong.We also got some insight into the safety and tolerability of the drug as part of the same presentation. Bottom line, there are no real issues. This side of the study is something that many speculated may be behind the above-noted screening and enrollment halt, but the numbers from the presentation show otherwise. As per the presentation, only 7 patients had an SAE “related” or “possibly related” to the DCVax-L treatments or placebo and, generally, AEs were related to underlying GBM or SOC/other treatments – 132 patients had SAEs considered unrelated to DCVax-L.Further, and importantly, the rate of adverse events with SOC + DCVax-L was (is) approximately the same as the rate of adverse events with SOC alone.So the drug looks safe and we have clear indication that it can be effective in a very severe portion of this patient population. For us, this is strongly indicative of a positive outcome come topline release.Nothing is guaranteed, of course, and we would be naïve to suggest that – for this company especially – there are going to be no more surprises around the corner. From a risk-reward perspective, however, this one is far improved from just six months ago, and as recent action shows, markets are starting to fall in line with this risk profile shift ahead of next month's report.Management also just closed on a debt financing, removing immediate near term dilution risk.Learn the whole story: check out our previous coverage here.We will be updating our subscribers as soon as we know more. For the latest updates on NWBO, sign up below!Image courtesy of Neil Conway via FlickrDisclosure: We have no position in NWBO and have not been compensated for this article.
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