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Northwest Biotherapeutics, Inc (OTCMKTS:NWBO) Just Gave Us A Timeframe To Watch For Its GBM Study

Northwest Biotherapeutics, Inc (OTCMKTS:NWBO) Just Gave Us A Timeframe To Watch For Its GBM Study
Written by
Chris Sandburg
Published on
June 6, 2017
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Regular readers will know that Northwest Biotherapeutics, Inc (OTCMKTS:NWBO) is one we've repeatedly come back to across the last twelve months. With its lead asset, DCVax-L, which is currently under investigation as a potential therapy for glioblastoma multiforme (GBM) brain cancer, the company has had one of the roughest clinical development experiences we've seen in a while – that is, at least, from an external input perspective.From a patient perspective, things are far less clear. The trial is blinded (we'll get to this in a bit more detail shortly) and other than periodic event-hit updates, and by proxy some still-blinded survival statistics, markets have no idea how it's performing.Neither does Northwest.We just got an update from management as to these events and, alongside the update, a reiteration of the time frames to watch out for near term.The company is staging something of a mine recovery on the latest news and – if the near-term catalyst comes out as positive – it's really going to run. Here's what we're looking at as supportive of this statement.For newer readers, we recommend checking out some of our previous coverage of this stock here. By way of a brief intro, it's a company that's developing what previously looked to be an incredibly promising immunotherapy program but that – for as yet unrevealed reasons – found the lead application of this program (the above mentioned DCVax-L) on the wrong end of a clinical hold for the better part of 18 months.The hold lifted earlier this year, at which point we learned that one of the two event-counts necessary to class the trial as complete had been hit – a count of 248 events for progression free survival (PFS), defined as primarily tumor progression (i.e., recurrence), although they can occasionally be patient deaths which occur without prior evidence of tumor recurrence. We also found out that the one that wasn’t hit, the overall survival (OS) count, was likely to take several months to reach its threshold of 233 events (this was early Feb).As part of the most recent update, which came by way of a booth-based conference call at ASCO, the company's Technical Officer, Dr. Marnix L. Bosch, revealed that this count had reached 231 events and that he expects the 233 threshold to come in by July.That leaves four weeks until the data is unblinded to an independent analysis team, who will then get to work interpreting it before handing over this interpretation to Northwest.There are a few key points here.The first is that, for whatever reason, markets seem to be interpreting the failure to reach threshold in OS as negative. This interpretation is wrong. The longer it takes to reach threshold, the longer these patients are living. This is a cancer that's incredibly aggressive and for which patients on this trial are surviving for more than 35 months.The second is that – despite what other media outlets might be saying – Northwest cannot conduct any sort of analysis on the results to date, even with the PFS threshold already reached. The data remains blinded until both PFS and OS hit and – even then – will remain blinded to Northwest until the above mentioned independent analysis completes.Sure, it's frustrating to a degree that the trial is taking so long, as it means the company is having to issue shares to raise capital while waiting for it to complete. Dilution aside, however, that it's taking this long is a great thing for the company and the patients being treated.Aside from the event threshold completion come July there's also a near term sarcoma study initiation and data from the secondary programs in the company's pipeline. These are very much second fiddle to the GBM catalyst, however. If the numbers point towards efficacy for DCVax-L, the company is going to take off.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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