NorthWest Biotherapeutics Inc (NWBO)

[longusa]

Red, Flipper, Excellent points. A possible way this would proceed if DCVax-L approved is to file an NDA right away for the improved process and propose a Phase III post-approval confirmatory trial; in this way, the improved version would get to patients in a matter of months after the initial DCVax-L approval. Given that the process will have proven itself in the DCVax-Direct trials, I would think the FDA would go along with this.

Similarly, I would hope the company follows this same idea in getting the DCVax-L label rapidly expanded to all solid tumor cancers. The FDA seems to understand this given the DCVax-Direct Phase I/II design that covers multiple cancer types right off the bat.

If this were done, NWBO would see the DCVax-L market opportunity expand from GBM to all operable solid tumor cancers in 12-18 months following initial approval. As well, I think big pharma and biotech analysts would also be thinking this way, with the pps likely reflecting it.