A company I used to work for once went through a process with FDA to gain acceptance of a new endpoint for an established condition. Essentially, the accepted surrogate was Mean relapse rate and they wanted to change it to proportion of patients relapsing in order to accelerate the time to study completion. There was a back and forth with FDA where the company made the case by showing a high degree of correlation between the two measures. Initially, data from one trial was submitted but FDA wanted to see that the correlation held up over multiple trials. I think in the end, three trials were submitted before FDA gave a positive response. This was not an “approval” And the company still had to choose to proceed at risk and hope for the best. They did so and in the end FDA accepted the endpoint after seeing the data showed a clear difference.
My point being, I think NWBO probably went through a similar process with FDA. They probably needed to show a fair degree of consistency across a couple trial placebo groups. One they did so FDA probably suggested they use the most conservative data set or perhaps the blended data set. FDA has been talking for some time now about considering the use of contemporaneous controls in oncology and other conditions with a high degree of mortality so as to avoid the use of placebo groups. I think here NWBO may have received a positive response after some back and forth, but in the end must proceed at risk and hope that the data is accepted. They wont get a flat out approval beforehand.
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