https://www.nejm.org/doi/full/10.1056/nejmra1510064 If the primary outcome is negative, positive findings for secondary outcomes are usually considered to be hypothesis-generating. Certainly, regulatory approval of a new drug is unlikely to follow. However, in some instances, secondary findings are compelling enough to affect guidelines and practice. For instance, in the ASCOT trial of amlodipine versus atenolol for hypertension,25 the hazard ratio for the composite primary outcome of nonfatal myocardial infarction or fatal coronary heart disease was 0.90 (95% CI, 0.79 to 1.02; P=0.11). However, the data supporting evidence of the superiority of amlodipine with respect to stroke, total cardiovascular events, death from any cause, and new-onset diabetes were overwhelming (P<0.001, P<0.0001, P=0.02, and P<0.0001, respectively) (Figure 1). In hindsight, the primary outcome was an odd choice: the decision not to include stroke in a hypertension trial is unconventional. These results support recommendations against the use of atenolol as a first-line or second-line antihypertensive agent. Few studies are appropriately powered to assess effects on mortality. Proper interpretation can thus be challenging when a large trial shows a reduction in all-cause mortality, which is plausible but not prespecified — especially if the primary outcome was negative. For example, in the MATRIX trial,26 patients with an acute coronary syndrome who underwent PCI were randomly assigned to receive procedural anticoagulation with bivalirudin or unfractionated heparin. There was no significant difference in the 30-day composite primary outcome of death, myocardial infarction, or stroke (relative risk, 0.94; 95% CI, 0.81 to 1.09; P=0.44). However, bivalirudin was associated with a markedly lower incidence of major bleeding as well as lower all-cause mortality (relative risk 0.71; 95% CI, 0.51 to 0.99; P=0.04), a result also observed in some previous studies.27 This finding of reduced mortality with bivalirudin, although mechanistically plausible, ideally requires an additional adequately powered trial for resolution.
The thread of the discussion was "failed trial" as in whether company would need to disclose. People were imprecise in language. Originally I had said a few days ago that "Failing to meet primary endpoint would need to be disclosed." That got muddied up in discussion. Failed trial is an imprecise way of saying a trial did not meet Sat Sig on its Primary Endpoint. That does not mean the company can not proceed with development or even seeking approval based on the results. People were thinking it is the Company is the one to decide if it failed. The Company decides what to do in the future but the assignment of p values comes from the Statisticians the pass/fail is whether or not p<0.05. A p>0.05 in the primary endpoint is by convention labeled as failed its pre-established primary endpoint. Does not mean it would be impossible to get approval just that it is a materially adverse event to the value of the investment in the case of a Registration Trial for Companies lead or very important drug. BTW sometimes a very good time to buy into promising Biotechs is after one of these failures. Because often there is a way forward. In biotech there are nearly always bumps in the road. But I see a smooth autobahn ahead for NWBO. There are two options either the Company has not recieved the Statistics Report or they did and at least the primary endpoint is p<0.05. The evidence that I see is that when the results are released the odds are much greater the the results will be good. But we can not say the results must be good because the company has not disclosed a primary endpoint of p greater than 0.05 (not Stat Sig) because we can not know whether they have recieved that determination: the Statistics report. The Company might not have the report yet. There are 3 options. 1. Company has report= primary endpoint met. 2 Company does not have report= a) primary endpoint met b) primary endpoint fail. The preponderance of the evidence we do have is that the trial results will meet primary endpoint but not because they have not released bad news because we have no evidence that they recieved the Independent Statiticians Report. But I would agree with others that the results of the blinded data from 2018 strongly points to overwhelmingly positive data coming when it is finally released.
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