NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

Great!! Thanks Doc!!

“Poly ICLC (Hiltonol®): an immune adjuvant targeting the Toll-like receptor 3 (TLR3) pathway; approved for subsets of patients with squamous cell carcinoma”

This should make it very easy for NWBO to provide already existent adjuvant data, doesn’t require an entire trial, to validate including it as an adjuvant with DCVax-L, as I have always said was the most likely process. It does require that they include that request in their application though and there are reasons first to get DCVax-L approved by itself first and then Hiltonol as an add on as well, so it is up to the company what regulatory strategy will be most expedited and most appropriate for validating DCVax-L.

Given the trials with poly iclc / Hiltonol, and there are 2 prior to the most recent combo with Keytruda and those are the ones with the amazing 5 year plus results people keep celebrating online. Dr. Liau has said the first tiny trial generated statistically significant results. Even on the basis of that, I would expect the company under newer regulations addressing RWD, can get insurance coverage including Hiltonol with DCVax-L, assuming FDA approval of DCVax-L.