NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

I believe that it was 2015 when they had the trial enrollment halt, though it was before I was an investor. In reality, that's when the trial was dramatically changed, and all 4 regulators agreed to that change. In so doing, the 4 regulators had to agree that the changes in the trial would result in different evaluation of results. At that time at the insistence of the German's it was agreed that all remaining would get the vaccine up front, the control was abandoned. I'm uncertain if at that time they were fully aware of pseudoprogression, but I believe they knew that OS would become the primary goal.

Changes such as this take a great deal of time to proper document and take substantially longer to get all four regulators to accept the same exact criteria for judging the results. I don't know for certain, but believe that the SAP that was finally accepted was identical for each of the regulators. Investors never were shown the SAP but it clearly resulted in the changes made by the two European regulators.

People can try to cast doubt as to what happened, but I believe that if you look back at the halt, then look at how the trial was changed when it resumed, you have to conclude that this is when the trial was dramatically changed. After that it was all about getting all the changes documented and agreed on by all four regulators.

Gary