NorthWest Biotherapeutics Inc (NWBO)

[ATLnsider]

The DCVax-L Phase III clinical trial is over. The old terms of the Cognate CDMO agreement are no longer applicable. DCVax-L has not been approved by the FDA or Health Canada yet. There is no need to rush to update the Cognate agreement yet.

The time was better spent on building out Sawston and getting the facility GMP licensed by MHRA. Now NWBio can get DCVax-L approved in all 4 regions now, the US, UK, Canada, Germany and the rest of the EU.

After TLD and the journal article are released, then NWBio can complete the DCVax-L BLA / MAA submission process in all 4 regions. NWBio will then have 4 to 6 months before DCVax-L regulatory approvals to work on updating the Cognate / CRL CDMO agreement. By that time, NWBio will have more clarity and be further along in the Flaskworks development and certification process. All of this can be done in an orderly and timely manner.