I don't think NWBO knows that the trial failed to meet the end-points but I submit that they they have a pretty good idea given the data they already have, and of course, input and advice they obtain from their professional statisticians, the SAB and the principal investigators.
The fact that PFS was ignored in the JTM article is very telling, at least to me. Yes, there is the issue of confoundment with respect to pseudo-progression. However, I think that due to this issue, the blended data on PFS may have been too close to call at best and it was then hoped that adjudication at the conclusion of the trial might help bring PFS over the primary end-point line. If even with adjudication, the PFS primary end-point is not achieved, this may be perceived as a significant negative.
However, IMHO, failure to meet this primary end-point is not necessarily a considerable negative IF NWBO can explain it properly. For example, as I have alluded to a number of times, PFS is a surrogate and perhaps not entirely appropriate in evaluating immunological therapeutic approaches. These therapies take more time to manifest their efficacies than SOC(chem/rad). Accordingly, and I am speculating, there may have been earlier than expected PFS eventing because the therapeutic effects of the vaccine needed more time to take hold, and even though there was earlier eventing, the rate of its' progression was slowed and the delta between PFS eventing and OS was increased thus resulting in patients living longer than expected.
While I think that lack of SS/failure to meet the primary end-point will not necessarily result in failure to gain regulatory approvals or result in rejection by the medical community, I do think that it will still weigh heavily on the share price. No doubt, the bear investment community will trumpet the failure to meet "the" primary end-point thus keeping a lid on any significant rise in the share price and thus engendering fears of continuing toxic financings until less than reasonably certain reg approvals which may not be near term in any event. If there is lack of SS/failure to meet the secondary end-point, this will further compound negative perceptions by the investment community even though other data may be highly favourable and suggestive of efficacy. It depends very much on how top line is presented and, of course, the strength of the data. JMHO.
