Replies to post #766962 on NorthWest Biotherapeutics Inc (NWBO)

[Chiugray]

SkyLimit, Agree, that is an important point. NHS expanding the indication from GBM to Cancer doesn't necessarily mean the MHRA will do so too.

At a minimum, this does mean the NHS is confident DCVax-L is very applicable to "Cancer" and wants to influence future regulatory strategy by supporting it with $$$ funding and to gather real-world evidence across cancer types.

Also it is very possible what DocLogic states is the case:

I actually suggested in a post a while back that the additional 700,000 pages could include documentation related to this since the proteomics data had been developed and revealed. Biomarker confirmation was also presented I believe by Dr. Linda Liau at one point and the proteomics by Dr. Bosch in a presentation shared on this board.

What this all points to is a BIG proactive move by MHRA and NHS to advance the tissue agnostic validation process.

Another scenario and alongside the above.
The MAA had also included in it the UCLA's Phase 2 brain tumor clinical trial data (DCVax-L and poly-iclc) as additional supporting information. Included in that data was a small data set for grade 3 glioma brain tumors. Where external survival data shows average survival at 27% at 5 yrs, this UCLA trial showed 100% survival at 5 yrs and 75% survival at >10 yrs. Based on that, the MHRA can decide to include the label of Grade 3 glioma brain tumors.