NorthWest Biotherapeutics Inc (NWBO)

[SkyLimit2022]

exwannabe,

Randomized setting? Are you referring to the randomized setting of the combo study at UCLA?

The DCVax-L cell-based platform technology has been under clinical investigation for a significant period of time, and the overall clinical data in total include three trials spanning many years. Safety and efficacy data have been gathered from trials with external controls and trials with placebo controls. The data include DCVax-L as a monotherapy and in combination with other agents.

The interim PD1 combo data are brilliant, and the trial is significant for a number of reasons relating to FDA guidelines and NIH peer-reviewed grant funding.

https://clinicaltrials.gov/ct2/show/NCT04201873

https://www.fda.gov/media/120721/download

In the combo trial, patients who receive DCVax-L + placebo are being compared to patients who receive DCVax-L + pembrolizumab.

The control arm is receiving DCVax-L. While DCVax-L is not the current SOC, it is highly significant and notable that DCVax-L is being permitted to fill the role of SOC as the best available therapy within this combo study for rGBM. The combo trial also follows the P3 in sequence which in itself validates the findings of the P3 study—the placebo group in the PD1 study would not be receiving DCVax-L today if the preceding P3 trial had not proven its efficacy.

https://brownneurosurgery.com/breakthrough-brain-cancer-vaccine/