NorthWest Biotherapeutics Inc (NWBO)

[Umibe5690]

You can take that to the bank. The FDA/Hahn and Pazdur are on board. They understand the new immunological paradigm. The FDA guidelines have been written with a lot of carefully thought input from NWBO. There has been discussion about P-values and their application. However, they don't necessarily apply when everyone is living longer including late vaccination. Linda's letter is on point wrt to P-values and sub-groups This is an important area and has been addressed extensively in the SAP on which the FDA has made comments. BTW, would not doubt that several of the 800 statisticians were involved with NWBO. JMHO.