NorthWest Biotherapeutics Inc (NWBO)

[ATLnsider]

I believe it is this FDA steering this DCVax-L review and approval ship (via Project Orbis). The DCVax-L clinical trial IND was first approved by the FDA and started in the US in 2006, and all the DCVax-L clinical trial sites were initially only in the US. The trial sites were later expanded to Germany and the UK in 2012, and then to Canada in 2015.

The FDA has been and will always be the lead regulatory agency for the DCVax-L Phase III clinical trial. In order for DCVax-L to become part of the new SOC to treat ndGBM and rGBM, the FDA will have to take the leadership role in this effort. The UK is too small (population 67 million) to create a new global SOC. The world needs the US (population 329 million) to lead this effort. The FDA and Dr. Pazdur know this.

Here is another “oldie but goodie” post from May 2021:

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=164085000

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.