NorthWest Biotherapeutics Inc (NWBO)

[HyGro]

Well. NCI and UCLA (Dr. Liau) are using PFS as their lead efficacy endpoint for the rGBM Keytruda combo trial (using immunotherapy). Now you have dualling clinicians with different opinions.

FDA guidance lists 6 different oncology (tumor) trial endpoints as acceptable for approval consideration. PFS is one of them. https://www.fda.gov/media/71195/download

NWBO has repeatedly reported that the OS data is confounded because of the crossover. From their SEC filing: "Both of these endpoints were confounded: the PFS endpoint by pseudo-progression, and the OS endpoint by the “crossover” provision in the trial design, which allowed all of the patients in the trial to cross over to DCVax-L treatment after tumor recurrence (while remaining blinded as to which treatment they received before tumor recurrence)."

Peer-reviewed article on confounding concluded the following as a results of confounded data: "Confounding factors may mask an actual association or, more commonly, falsely demonstrate an apparent association between the treatment and outcome when no real association between them exists."

FDA knows this and will not be enthused with a manipulated trial (complete post hoc protocol/SAP redo) and the confounded data that questions the validity of the data. That's why investors aren't buying it and the share price has actually declined when the TLD was released.