A. LP price tag way out of whack with what BP considers reasonable? What is reasonable? Apparently, $50B MC doesn't sound reasonable to NWBO. OR,
B. The trial failed and big P knows it? I doubt the trial failed. Perhaps PFS and separation are confounded and ambiguous. That is possible. But..........
1. Blended results at least as good as Optune:
2. Looks like a strong long tail and this is an important part of the OS data set which is the "gold standard":
3. Looks to be especially effective on M+ which represents about 44% of the categorised M+/M- population and close to 40% of the entire trial population:
4. Looks to be effective, to some degree, on other molecular groups especially MES. If so, effectiveness on over 50% of the trial population;
5. Excellent safety profile;
6. Patients need alternatives to SOC and Optune. If DC VAX L is just as effective as Optune in the front end stages but more so from a long tail perspective, patients should be availed of this alternative;
7. Ease of administration;
8. Manufacturing readiness;
9. Pricing and meeting QALY criteria--insurance.
So, if the foregoing is likely, and I think the odds are quite favourable, the trial has definitely not failed and NWBO has built a formidable data set that can demonstrate results are fairly well undeniable.
If so, then why hasn't someone from big P, world wide, broken ranks and engaged in serious discussions?
1. Maybe they have and we just don't know. The veil of silence is such that thus far no leaks;
2. Maybe there have been informal "feelers" from big P but LP has shown little interest in these "feelers";
3. Maybe big P is waiting for results confirmation. They know that LP will give them NO DISCOUNT either before or after unveiling results, so why not wait until after results;
4. Maybe there is a conditional deal dependent upon results;
5. Maybe the asking price is ridiculously high, say, $70B~$100B;
6. Maybe big P thinks it can get the FDA to at least delay any determination on approval(and NWBO knows this thus their continuing the trial to make results undeniable--a confirmatory trial decision by the FDA would be a disaster for NWBO so continuing this trial for a while longer takes the place of such a possibility);
7. Maybe the trial failed, LP/LG know it but are continuing all the while milking the company through compensation and favourable interest rates all in collusion with the SAB, PIs including LL and 69 authors of the JTM article. SOS is part of all this as are Bigger and Rago. The case dismissals were effectuated by buying out the judges and the SEC is toothless as in "who's afraid of the big bad wolf".
Take your pick. I have made my choice. My vote? Oh yeah, right now my inclination is to vote yes while holding my nose. Hope the ASM attendees ask the hard questions, follow up and demand answers or why they can't get them. Depending upon the ASM, I may change my mind. Attendees should also make this clear at the ASM. LP/LG no longer get a free pass. Time for some accountability, even if the odds look favourable by reading the tea leaves.
JMHO.
AI
