NorthWest Biotherapeutics Inc (NWBO)

[Pyrrhonian]

The most important thing the public is being made aware of is the overwhelming evidence that DCVax-L is effective, and will almost certainly exceed its target primary endpoint, becoming the new standard of care (SOC) for ND-GBM.

It's been a long time in coming, as many GBM sufferers and their families know only too well. In the last 50 years surgical procedures have advanced, increasing patient's survival time from several months at most to over 12. Finally, in 2005, Temodar came out, adding 2.6 months median overall survival (OS) to that, bringing the median life expectancy up to 14.6 months from diagnosis. Meager, but it was something.

Surgical procedures in the last decade have advanced even further, raising that 14.6 months up to 16 months. However, in all of that time, over 50 years, only one therapy has shown to improve OS at all for GBM sufferers--Temodar, adding just 2.6 months.

This 16 months median OS with best surgical procedures and the ONLY effective treatment on the market (temozolomide) may finally, at long last be improved upon. And not just by a little bit--rather, a total coup, raising median OS to some 36 months, more than doubling what is possible with best SOC alone.

Listen, I'm excited to see data on DCVax-Direct, and think it has amazing promise, but the main reason I'm invested in NWBO is the absolute confidence I have in the success of the ongoing Ph III DCVax-L trial, which will likely end in an early halt next year (imho). And given there is absolutely no competition in this space, a very rapid market saturation and an immediate $3B-$6B market cap. That is just for ND-GBM. Then there is label extension, beginning with psPD GBM, rGBM and lesser gliomas, which I think the trial itself will have enough data (in addition to Hospital Exemption open-label data) to garner at least Accelerate Approval for--then on to trials for label extension for other indications entirely. In the US and EU, that would make for over 60,000 treatments/yr at $70K/tx (conservative) or $4.2B in sales. Quickly..

DCVax-Direct, once it comes further along in trials, will likely follow suit, as it is such a novel conceptualized therapy with good patent protection and really nothing like it by comparison, and clearly showing early signs of strong efficacy. But I'm not putting big (for me) money into NWBO because of DCVax-Direct (yet). I'm doing it because of DCVax-L. And I don't think you'll ever again see so much foreshadowing of a treatment's effectiveness before the release of clinical results in an ongoing, double blind Ph III trial like we have here.