NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Maybe somebody already tied up the thoughts I’m about to comment on. If so, sorry.

We know Dr. Pazdur believes any new therapy about to become standard of care must be ready to ramp manufacturing quickly to meet international demand, and in order that it be used as control arms in future trials.

We know LP has been tasked with keeping a lid on prematurely signaling results and yet, in Sawston, for instance, still demonstrating NWBO has 20 times the expansion room, plus future automation capacity to assist with a fast manufacturing ramp that Dr. Pazdur wants for future SOC as discussed in the previous paragraph. (I did not even go into Cognate/CRL capacity to achieve this in North America)

Anyway, that’s not exactly what I wanted to point out. Instead, I want to pick up on the potential ability for DCVax-l to become the clear SOC (with and w/o TMZ). WHO’s redesignation of GBM, as we know, serendipitously makes it more likely DCVax-l will become SOC for all newly diagnosed GBM as now defined, and thus it makes future trials that would then use DCVax-l, as a control arm, compete with DCVax-l on a very clear diagnosis, avoiding confoundment by idh mutation and H3 mutation (the former typically occurs in late childhood and very early adult, the latter typically in children).

Essentially, all comers that wish to challenge DCVax-l in treatment against GBM, will presumably do so without being able to front load their trials with less aggressive IDH-I mutation in treatment arms of unblinded trials (ahem NVCR cough Optune).

Meanwhile, the search for true treatment of non-GBM (idh and H3 mutation) can aggressively be pursued separate and apart from GBM trials, because even though it is less aggressive on average, it is still ultimately deadly and thus in need of very focused attention.

Also, due to the new definition of GBM, both GBM and IDH mutation are separately more likely to remain orphan diseases, because the split will automatically reduce their prevalence. This is important to maintain focus on these very stubborn cancers.