If the proof were irrefutable then it seems self-evident that it would not take such a long time to analyze the results, because irrefutable proof would mean that a high schooler would be able to see that DCVax-L beats standard of care.
As you mentioned, getting irrefutable proof was why so much extra time was tacked onto the trial by adding patients and then moving the goal posts from Progression Free Survival (an endpoint originally chosen to save time, lives and money) to Overall Survival
Possible Positive Explanations for the Delay in TLD:
1. Maybe the data is irrefutable and NWBO management has conditioned themselves to be so pathologically careful that they worry about everything being perfect to the exclusion of everything else and to the detriment of patients (who have a very short time frame to work with indeed) and shareholders, who while not holding options, still get hammered by dilution the longer this drags on.
2. Maybe the data is irrefutable but NWBO is, as has been suggested, waiting for Inauguration Day or a little after so that they hand TLD to the FDA leadership that will be there the next 4 years, avoid DCVax-L from being drowned out by the noise and also from being used as a political football by the outgoing and incoming administrations. I understand that they cannot come out and say that, for multiple reasons.
Possible Negative Explanations :
1. NWBO has data that might pass muster but is nowhere being irrefutable and so they are having the statisticians flip it upside down, look it through a Funhouse mirror etc. to find subgroups etc. and thus our shot at approval goes from being almost a sure thing (barring FDA corruption of course) to being something where we might still win approval or where they say "This looks interesting but you have to do another Phase 3"
2. NWBO has been running a scam and as some people said knew the trial failed 5 years ago and this tracks with the 'pending' efficacy review that was supposed to happen but didn't etc. Personally I believe this explanation is far-fetched but by playing bait and switch and being deliberately nebulous, moving goalposts, communicating through plausibly deniable cutouts, NWBO management has worked hard to perpetuate this theory. Now maybe they are doing what the Air Force is doing with the Aliens at Area 51 cover story and being able to fly new airframes in plain sight and folks will dismiss the footage shot by people as 'UFO's' when they would really be of interest to foreign powers otherwise, in short, perhaps NWBO acts crooked and feigns weakness to hide strength until the right moment.
I just don't know, and I do not believe anyone else here does either but we're about halfway done with January 2021 and I would not be more than mildly surprised if January 2022 rolls around and we do not have TLD.
