NorthWest Biotherapeutics Inc (NWBO)

[ATLnsider]

I really like these sections of page 12 and 13 of the lawsuit. It sheds more light on NWBio plans to file for tissue agnostic approvals for DCVax-L across multiple solid tumor cancer types.

Also, it shows that NWBio is currently working on BLA / MAA submissions with multiple regulatory agencies :

Case 1:22-cv-10185 Document 1 Filed 12/01/22

In addition to these results from the Phase 3 trial, DCVax-L is also expected to have broader value in the future through: (i) potential combinations with wide range of other treatments; (ii) potential application to any type of solid tumor (i.e., a tumor in any tissue); and (iii) being feasible to administer in community settings (where most cancer patients are treated) as well as in major cancer centers. The Company believes this is the first Phase 3 trial to demonstrate any survival benefit from a systemic treatment for newly diagnosed GBM since the approval of Temozolomide in 2005, and the first Phase 3 trial to demonstrate a survival benefit for recurrent GBM in nearly 30 years. The fact that DCVax-L can potentially be applied to the treatment of any type of solid tumor is similarly groundbreaking, and would greatly expand the potential use of DCVax-L in the United States and worldwide.

NWBO is currently working with teams of expert consultants on preparations for filing applications for regulatory approval to bring DCVax-L to market for patients