NorthWest Biotherapeutics Inc (NWBO)

[HyGro]

NWBO has announced the confounding of the now New primary endpoint:
From the NWBO SEC 10K:
"Under the Protocol the primary endpoint was progression free survival, or PFS, and the secondary endpoint was overall survival, or OS. 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). The statistical analysis plan uses external control patients rather than within-study controls. There can be no assurance that regulatory authorities will allow a product approval to be based upon this approach."

NWBO has been saying it, I'll believe them as this is under penalty of perjury.