NorthWest Biotherapeutics Inc (NWBO)

[CherryTree1]

The ICT-107 P1 paper you reference was published in 2016. Things have changed with the FDA. I posed this last week, FDA Director's speech from this past June. Perhaps you missed it:
https://www.fda.gov/NewsEvents/Speeches/ucm611623.htm

Remarks by Dr. Gottlieb to the National Comprehensive Cancer Network Policy Summit
Pivotal trials testing these products are also likely to have crossover designs, meaning that if a patient’s cancer grows on the comparator treatment, then the patient is switched over to the experimental arm. Both arms receive the experimental drug, although in different sequence. Statistically, this may make it difficult to show an overall survival advantage for the experimental arm. Patients aren’t left on the comparator arm for long enough to show that they would have died sooner if left off the new drug. There’s a simple bottom line here. When new drug shows a robust effect on things like tumor size or tumor progression, patients are understandably less willing to forgo a new therapy in the name of a good “p” value.

It is worth taking the time to read the whole speech, very relevant to DCVAX.