NorthWest Biotherapeutics Inc (NWBO)

[HyGro]

FDA doesn't "approve" the changes to a pre-approved clinical trial protocol, The sponsor must file the changes, but FDA doesn't approve the changes. It is only considered when the sponsor wants to file future trials or when the sponsor files for commercial approval. Read the FDA Guidance on protocol changes.

When NWBO is under oath, under penalty of perjury, they are making statements that are different:
"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."

Sure says NWBO doesn't have "FDA approval" to all the changes to the protocol that were made,