NorthWest Biotherapeutics Inc (NWBO)

[ATLnsider]

The FDA held a Project Orbis Grand Rounds presentation on May 13, 2021, along with Health Canada and Swissmedic, to discuss how Project Orbis works, and the benefits of having concurrent submission, review, and almost simultaneous approval of NDAs, sNDAs, BLAs and sBLAs in up to 6 different countries.

This presentation was very interesting and informative. In particular, it was noteworthy what Dr. Richard Pazdur says around the 30:45 minute mark, regarding the reasons why the FDA started Project Orbis, and the benefits of establishing a new global standard of care (SOC), especially for a “truly important Breakthrough therapy drug”.

https://collaboration.fda.gov/pbq6126oijaa/

I still believe that NWBio will utilize the FDA Real-Time Oncology Review (RTOR) and the Project Orbis programs to get expedited global regulatory approvals for DCVax-L. These programs will also help establish DCVax-L as the global SOC for ndGBM and rGBM, and will help pave the way for future global combination trials for DCVax-L, along with global trials for DCVax-L and DCVax Direct to treat other solid tumor cancers.