NorthWest Biotherapeutics Inc (NWBO)

[HyGro]

Read the press release, there is nothing stating the SAP was being completely changed. It wasn't until the TLD was released that the recurrent GBM arm was announced.

In addition, the datalock is quickly followed by unblinding required for statisticians to do the preliminary TLD. The unblinding is a quick procedure as is the preliminary TLD with PFS and OS endpoints. NWBO would have to know the recurrent GBM sample size -- otherwise they couldn't commit to doing a rGBM arm. It was never part of the original trial protocol or SAP.

The name of the trial is: "Study of a Drug [DCVax®-L] to Treat Newly Diagnosed GBM Brain Cancer (GBM)"