NorthWest Biotherapeutics Inc (NWBO)

[SkyLimit2022]

Thank you for highlighting this aspect of the P3 that is often misunderstood. The FDA, the P3 investigators, and others have recently spoken on this topic.

“Crossover was necessary for feasibility and ethical reasons:

—Necessary for enrollment and retention of patients in an era when immune therapies are not yet generally viewed as promising for cancer

—Important to justify all patients undergoing invasive leukapheresis procedure

—No benefit to placebo patients unless they could receive their autologous product made from the leukapheresis”


"Often, novel agents are so obviously superior to standard of care that no patient would participate in a randomized trial knowing that somebody else might get the experimental drug”—Richard Pazdur, MD

Richard Pazdur, M.D. is the director of the FDA's
Oncology Center of Excellence (OCE), which
leverages the combined skills of the FDA's
regulatory scientists and reviewers with expertise in
drugs, biologics and devices to expedite the
development of novel cancer products. In his role as
director of the OCE, Pazdur is responsible for
leading the effort to develop and execute an
integrated regulatory approach to enhance the
cross-center coordination of oncology product
clinical review.

https://www.annalsofoncology.org/article/S0923-7534(22)00006-0/fulltext