NorthWest Biotherapeutics Inc (NWBO)

[highwayman4life]

Understood and valid concerns given the sheer length this trial has been going on. Times have changed and the FDA along with other RA's recongnize this.

I feel the changes and buyin to the SAP by all 4 RA's was and is crucial.

Also take a look at FDA RTOR program:
https://www.fda.gov/about-fda/oncology-center-excellence/real-time-oncology-review

It is my opinion that NWBO has long been in constant communication with the FDA and to how to best approach the success of DCVax in spite of an archaic chemo/rad cancer trial designs.
https://acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.33205

We will know soon enough if in fact NWBO is paving a new pathway for immunotherapy clinical trials designs/outcomes...hence the quiet period. Change never happens quickly, especially necessary change.

Best to you and the success of this long awaited trial and it's outcome.