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Northwest Biotherapeutics Inc (NASDAQ:NWBO) Is About To Turnaround

Northwest Biotherapeutics Inc (NASDAQ:NWBO) Is About To Turnaround
Written by
Chris Sandburg
Published on
December 14, 2016
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Northwest Biotherapeutics, Inc (NASDAQ:NWBO) shareholders have been waiting for some level of insight into its brain cancer trial for more than twelve months. Since enrollment came to a halt last year, the company has refused (or been unable, which is very possible) to serve up clarity regarding the reason for the hold, and arguably more importantly, the status of the trial as things stand, and what we can expect moving forward.That is, until now. Well, sort of.At the end of last week, Northwest Biotherapeutics put out a press release concerning the study in question. It was pretty vague, but in a landscape where all investors have had to go on is scraps of speculation, it's a more than welcome bit of interaction.Here's our take on what the release said.For those not familiar with the situation, we pretty much summed it up above, but here's a quick recap. Northwest Biotherapeutics is a development stage biotechnology company working on a number of iterations of its dendritic cell immunotherapy asset – DCVax. It's a personalized oncology treatment, and it has shown considerable promise in a variety of different cancers in early stage trials.One of the most closely watched of these, and in terms of development pathway the most advanced, is a brain cancer indication targeting a type of brain cancer called glioblastoma multiforme. It's the most common solid tumor brain cancer, it's extremely aggressive, and it's really difficult to treat.Northwest is going after GBM with a version of its asset called DCVax-L, and its currently under investigation as part of a phase III study. The study initially aimed to enroll 300 patients, but then Northwest increased this to 348. Then came summer 2015, and the company announced it had stopped enrolling in the trial at the FDA's request. Markets widely perceived this as a precursor to discontinuation, and Northwest took a hit. Since, its market cap has gradually declined to just a fraction of its then-value.So that brings readers up to speed – what have we learned from the latest release?Well, it's worth saying to start with that the enrollment halt was just that – a halt on enrolling new patients. The patients that were already enrolled were able to continue treatment, and one of the burning questions since the halt has been how many patients did the company manage to enroll before the halt.As per the latest release, we now know that there are 331 patients enrolled. That's a 95% enrollment rate – not bad. We also know that the company has decided not to bother enrolling the last 17 patients, given the time it will take to do, and the time it will add on to the end of the trial before it can draw to a conclusion. Some may see this as bad, we don’t. Time added on is cost added on, and in the wake of a delisting, added trial cost is the last things Northwest (or its shareholders) need right now.So what's next?The trial is event driven, and these events are tumor recurrences and deaths. On deciding to complete enrollment at current levels, Northwest requested some information regarding the current state of these so called events. The company has some information in hand right now, but it's not going to be ready for report for a couple of weeks. This report is going to be huge.That's what we're looking for, and that's going to determine the company's market capitalization near term.One final note. That the trial hasn’t yet reached its predetermined event rate is a positive sign. GBM, as mentioned, is very aggressive. Progression free survival is very short. If the event threshold hasn’t been reached yet (and we're assuming it hasn’t based on the latest PR) then it suggests the treatment is extending PFS in the patients that have already been enrolled.We will be updating our subscribers as soon as we know more. For the latest updates on NWBO, sign up below!Disclosure: We have no position in NWBO and have not been compensated for this article.

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