NorthWest Biotherapeutics Inc (NWBO)

[ATLnsider]

Thanks Baxers‼️It’s good to see definitively that all of the regulators, including MHRA & FDA are aligned on the fact that NWBio did not use RWD in its DCVax-L Phase III trial. As you may remember, I got a similar response directly from the FDA.

NWBio used pooled data from other contemporaneous randomized controlled trials (RCTs) to develop its ECA.

This type of ECA is allowed by all of the regulators, but it is not considered RWD.

Also, it’s good to know that NWBio has years of individual patient-level real world data (RWD) from its own Compassionate Use / Specials program, where they have treated hundreds of solid tumor cancer patients in the U.S., UK, Canada and the EU.

This RWD that NWBio directly owns could be used to help support the expansion of the DCVax-L approved label from beyond only newly diagnosed and recurrent glioblastoma (GBM), to include all or most other solid tumor cancers.