NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Yeah, anger is one way to manage that, but instead, if you watched the design development and patenting of DCVax-Direct, you’d see it was fine tuned, literally to the hour. They learned not just to partially mature, but how to improve some patients’ DCs in the case where the patients’ cells were otherwise not going to produce enough cytokines when intratumorally injected. To do this, they first had to develop methods to ascertain DC maximum potential, then select for that potential, and finally, in some cases, actually instill or promote that potential with manufacturing techniques/ingredients.

What transpired is a more aggressive but amazingly safe therapy. The new method was just patented, because the best version was finally determined and able to be produced through partial maturation/activation, and in a percentage of individual cases, if needed, adjusted to meet the required threshold for quality and cytokine production.

Now, yes, now they could be starting a phase ii/iii, but because the technology is so closely associated with DCVax-l, if they did start before L approval, any hiccups Direct met along the clinical trial path (remember, it is more aggressive) might slow down approval of L.

So, L, whether you know it or not, is now more efficacious against GBM than it was before, because in the past year, the definition of GBM changed, and that change happened to match L’s immunotherapeutic method of action even better. If L would have sputtered out of the gates, NWBO might fall into the Dendreon trap. Dendreon neither had a lower cost manufacturing system, nor did it really stand out among its competition.

On the other hand, L has developed a lower cost manual manufacturing process, and in the foreseeable future will transition to an even lower cost closed system automated manufacturing system. Now, what about its competition for GBM therapy at this late moment in time? Lomustine and Avastin are essentially out. Optune leads to a higher rate of distant tumors and can’t prove true long term efficacy. Monotherapy with Temodar can only somewhat help methylated MGMT GBM (not unmethylated) (under the new GBM definition), monotherapy with Checkpoint inhibitors failed again and again.

The wait for DCVax-l has been intolerable, but it is now set up to succeed on efficacy, economic manufacturing and against competition like never before.

I do believe it will succeed on all these levels now, and its heralded success will likely initially allow DCVax-Direct to enter the scene on L’s coattails. Ultimately, in a few years to come, Direct could eliminate the need for surgery in many cases and many cancers, not only due to its MOA, but also because the ability to detect 50 types of cancer much earlier has exponentially improved this year. Combine that with the power of Direct, and the future looks very very bright.

And I believe in the future
We shall suffer no more
Maybe not in my lifetime
But in yours I feel sure — Paul Simon