NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

Biosect,

In the case of Gleevec I believe a trial that was supposed to go to several hundred was stopped with under 80 because it was clearly saving lives. While the DSMB's primary function may be safety, I believe they can advocate to end a trial at any time they're convinced a product shouldn't require further testing to be approved. I can't say how often the regulators actually accept their recommendation, and of course no documents are ever revealed of such recommendations unless action is taken that's based on what they're recommending.

Clearly I'm advocating that the regulators use their own eyes to see what's happening in the clinic and not rely on only the statistics generated in the trial, especially when the DSMB recommends doing so. No one should need to know more than the statistics on the Top 100 or roughly 300 who received the vaccine to know that this should be approved immediately.

I believe the fact that in the U.K. Dr. Ashkan is free to offer DCVax-L to patients with all forms of solid cancers under compassionate use is amazing. I've heard of many people attempting to get drugs under compassionate use, in some cases the company supported it, in other cases they didn't. The point is, they never solicited it. Dr. Ashkan appears to be openly saying it's available, come and get it if you can afford it under provisions of compassionate use. By the time we have approval he may have substantial evidence of it's use in other cancers even if it's only six months or so under treatment with it. A substantial anecdotal database should be established in just a few years.

I guess that what I'm saying is, the regulators can make the choice to greatly expedite approvals when they so choose. Clearly Covid-19 has been handled in this way, much the same could be done with deadly diseases like cancer. An EUA could have been issued back in 2018 based on Top 100 alone, that could have permitted it's use covered by insurance until sufficient data was gathered for full approval, if it can be done for Covid-19, why not cancer. I know we don't have hundreds of thousands dying of GBM annually, but for those who have it, it's far deadlier than Covid-19.

Gary