So, having (possibly) solved the riddle, the only question remaining is when this will be revealed — more than it has already? People might surmise the answer centers around how best to trap shorts, but logic and humanness point simply toward QALY valuation followed expeditiously by further and more comprehensive data revelation.
The regulatory moves toward accelerated valuations and reimbursement by NICE as a new way of doing business are not surprising in this regard. Valuation by ECA captures DC therapeutic power in newly diagnosed and recurrent Glioblastoma, but as some peer review seek to probe the confounded results, statistical significance there, imo, would not, obviously, necessarily and sufficiently ensure market survival without the horse (unconfounded OS ECA comparison = true value) before the cart (placebo control comparison = diluted value).
Consequently, once regulators value, and peer reviewers understand unconfounded results, then, aside from also confirming and explaining immunological method of action, which Dr. Bosch presented at ASCO and will
further elaborate at SNO, and aside from initial commercial manufacturing capacity for UK now firmly in place, what constraints remain?
None, imo. The simple expectation by still doubting Thomases should be, at most, “OK, your unconfounded results are great, but surely revealing the confounded results
would, bare minimum, display trending if not statistical significance as well, albeit diluted by crossover efficacy impact.”
Purest ECA advocates might complain that crossover patients received their first doses of DCVax-l after immune suppressing Temodar use was halted, thus not only must one account for crossover impact, but reduction of concurrent immune suppression as well — specifically when the initial therapeutic response may be better without TMZ confoundment. Thus, why expose that old OS comparison to the light of day when we have our ECA comparisons and Dr. Bosch’s immunological confirmation?
Fortunately, if I am right about the data and Doctor Liau’s reference to Dr. Musella about the six “dropouts,” the 65% crossovers and consequent confounding impact therefrom was still not enough to prevent DCVax-l from demonstrating statistical or near statistical significance in overall survival against 99 placebo control — albeit it muted by confoundment from 65% crossover.
When?
To me, after QALY valuation is “cemented.”
Again, QALY evaluation timing is being accelerated by MHRA as a new way of doing business.
I don’t think anyone is playing the public, I simply believe, for market survival, unconfounded valuation must be cemented before diluted/confounded results are revealed. As that time nears, “bear” traders might do well to sheer their own figurative fur as an offering to perennially persecuted longs. Oh wait, maybe we have seen a sign of such contrition. A would be competitor falling from 232 to 10 PPS in two years. Apparent awareness by more and more critics that they might have been wrong and will be utterly trapped if they don’t exit short positions with all due speed. Although, they don’t seem to be moving just yet.
The irony of this prior long painful journey, is not is just the recent implosion of NVCR turn of events, but it is that NVCR once, imo, severely unduly benefitted by exploiting censoring and thus manipulating result aesthetics, HOWEVER, NWBO will ultimately reverse their own implosion by patiently unveiling what it looks like when a successful treatment does not exploit censors. The ironic conclusion has been a long time coming.
Perhaps what’s more striking, is just how fragile patient therapies were to competitors not afraid to bend the KM curve via scurrilous methods.
