NorthWest Biotherapeutics Inc (NWBO)

[ATLnsider]

DJPele, another common misunderstanding that some people have regarding Project Orbis, is that NWBio would have to have a separate DCVax-L BLA / MAA submission date for each different regulator.

They mistakenly believe that NWBio would make 1 submission to MHRA, then 1 submission to FDA, then 1 submission to Health Canada, etc.

However, this is not correct. If NWBio utilizes the Project Orbis program for this submission, there would only be 1 submission to the MHRA only.

Then, the MHRA would forward the same DCVax-L submission application to the FDA for entry into the Project Orbis program. Then the FDA would forward the same DCVax-L submission application to any other Participating Orbis Partner (POP) country, who would also like to receive and review the DCVax-L application. These POP countries could include: Canada, Australia, Switzerland, Israel, etc.

https://www.gov.uk/guidance/guidance-on-project-orbis