I wonder whether NWBO is continuing efforts to automate DCVax-L manufacturing. They said in the 10K that they finished automating Direct, but did they give up on L?
"Win or Go Home" may be referring to an efficacy look for L, somehow, in spite of all the reasons that could not be going on. The difference between looking now and looking later is the threshold for statistical significance. 6 months vs 4 months PFS. And the difference between those two numbers relates to reimbursement, at least for the German HE program, and probably across the board. They may have decided that the reimbursement expected for 4 months PFS would likely not cover manual mfg costs. Therefore they are saying... lets just look at the data now and hope that we have 6 months for everything or subgroup(s) where we can be profitable without automated mfg now. Maybe a confirmatory for the 4 month looking subgroups would make sense... and they would continue development of automated mfg of L to make those subgroups profitable... while making money off of the 6 month subgroups now using manual manufacturing. That would support the trials now.
If so, the question for L is whether any subgroup meets statistical significance for 6 months PFS now. If one does, they have a means of supporting Direct development, and possibly a means of supporting automated mfg development for L for the subgroups with lesser efficacy, TBD. But if not... if no subgroup is showing 6 months PFS with SI now... then I think they want to move on to focus on Direct.
So if no automated mfg for L yet, then where did the money go? I have to rub LP's halo to make out the message... it says... Real Estate + Extremely Costly Automated Mfg Dev for Direct (Completed) + a very expensive attempt at developing automated mfg for L which they may or may not have abandoned at this point, but either way, is not complete.
