The bear case is fairly simple.
A) What happened back in 2015 was likely the exact same as what we now know happened with CVM. Upon a futility rec by the DSMB the sponsor elected to continue the trial. The FDA said fine, but you cannot ethically have patients sign the consent form at the initial screening. As with CVM, the trial continued but no new patients. And as with CVM once the trial IND was changed to have no more patient enrollment the FDA lifted the hold.
B) Whatever happened then, NWBO knows it. If the FDA had said anything to the effect that the trial doing so well no new patients are needed then NWBO would know they had a home run with the trial as of then. They would not been changing it to alternative endpoints and dragging in on 5+ years past when TLD would have been expected (even without an early efficacy halt).
C) Companies PR home run TLD as fast as they can for good reason. It does a lot more for advertising than tote bags. There is a reason why nobody has found a concrete example of a dev stage bio with positive P3 data not shouting it at withing a few months.
D) The attempt to change endpoints is post-hoc. Some here think that datalock is some hardline. It is not that simple. Changes to endpoints cannot be based on information from the trial. NWBO has significant data from the trial. The FDA action is huge. The blended data. The crossover numbers (that could worry them that the arm-arm OS comp would have problems). And that is only the certain known data.
E) Related to A), the fact that NWBO has been in a 7 year quiet period wrt the planned 2015 IA. NWBO had no problem going to war when they accused of hiding a bad rec in 2014. They had no problem subsequently talking of an efficacy IA in 2015. Then radio silence.
The bull argument always winds up with stuff like secret FDA actions, being afraid of the bears, setting traps for shorts and afraid of big bad BP.
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