NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Esoteric, but important from my perspective. It appears placebo stopped enrolling by around August 1, 2015. By December 2016, all but eight months of patients were beyond two years since enrollment. Patients were basically being enrolled at 10 x month during those 80 patients. Basically 27 placebo patients were enrolled during that time. The typical historical PFS event rate between 24 months and 16 months would lead them to merely 10% of those patients being non-progressed by the time December 2016 rolled around.

10% of 27 is 3.

There was a slide presented in December 2016 that, if read as it was shown, inferred that all placebos had PFS evented.

By simple historical standards, one might expect 3 patients in standard of care to remain progression free by December 2016, but remember, the DCVax-L trial excluded otherwise long progression free patients.

What happened since I first talked about most of this back at the end of 2016 and early 2017?

The placebo group got smaller. We thought 111 enrolled, but it was instead 99 enrolled, AND, the placebo group likely completed enrollments approximately three to four months earlier than we thought. If you add those additional facts, plus the exclusion of psPD patients that normally take longer to progress (if diagnosed correctly), one would be far more likely to predict that at the same time a slide was shown to the world in December 2016, if you simply read the slide fairly, that all placebo had pfs evented, this was indeed what should be expected at that time. Not tentatively guessed, but strongly predicted.

After the fact, that would leave about 83 patients from the DCVax-L group that had not evented, and zero from placebo. Now we know DCVax-L had 232 enrolled (not 221). 83 / 232 = 36% that would not have pfs evented by that time if the above is correct. By all other measures, that would mean success for DCVax-L with progression free survival. imho. After the slide came out publicly, the most experienced person on the NWBO board in manufacturing purchased 500,000 shares. In 2017 and 2018, the stock was heavily diluted due to Cognate debt being repaid, options going out, bonuses and the like. The long and short is that closely held shareholder ownership increased via debt financing and board/shareholder approved awards by extreme amounts in 2017 and 2018.

2016 may have seemed like a painful drop in pps, but 2017 and 2018 were massive dilution years for anyone that invested between 2012 and early 2016. Share ownership essentially went back to the company management, Toucan and Cognate in (late 2016) 2017 and 2018. For those with the knowledge and means to do so, they could average down, but outsiders were constantly barraged with uncertainty -- including that coming from the company itself -- remember "nearly 90?" Other than the example above, most share accumulation was not through purchase, it was instead through debt financings and bonuses. I'm not giving any opinion about whether this was kosher or not. I'm not knowledgeable enough to do that. But the reality is, by January 2017, if the above is correct, NWBO could have released PFS topline and applied for approval with the thought that although initially accelerated, it could - if OS successful -- be followed by OS for full approval. Good luck to patients and longs.