NorthWest Biotherapeutics Inc (NWBO)

[jimmy667]

This 100% correct and to the precise point and the reason for the requirement that public traded companies must immediately disclose events that a reasonable investor would think would adversely effect the value of the investment.
Failure of the primary endpoint in a trial designed to gain regulatory approval is a bright line determination and a materially adverse event for a companies lead compound. The Company does not look at the data and decide whether or not the trial passed or failed. That determination is made by the agreement of the three separate independent third party statisticians. They get the data and apply it to the pre-specified primary and secondary endpoints and assign a confidence interval against the null hypothesis and specify this as a p value. By convention the pass/fail line is p<0.05. The smaller the p value the less the result was the result of chance and therefore greater SAT SIG results.
This does not mean the company can not move forward with seeking approval but it does greatly reduce the likelyhood of gaining approval of the results of this trial and therefore must be disclosed to investors no matter how many silver linings might exist in the full data or secondary endpoints. Even if those secondary endpoints are so good as to have a good chance of approval. The test is would a reasonable investor likely reason that the failure to reach SAT SIG (fail) would materially negatively impact the investment.
Since it many times would mean another trial of course it is materially adverse.
But what I see as the dangerous assumption in thinking "the trial has not failed because the company has not disclosed a failed trial" is that NWBO has already recieved the report from the Independent Statisticians.
NWBO has not said they have it and the passage of time does not assure they have it. There is no evidence I see that it has been recieved.
I think the Company and Investors do have evidence to be hopeful even confident that the the results will be good and that the primary endpoint as well as secondary endpoints will be achieved.
I am confident of a good statistical report and the very good chances of approval.