NorthWest Biotherapeutics Inc (NWBO)

[iwasadiver]

I'm sorry, I'm still not understanding your confusion.

Direct P2 is a separate issue; today they announced that:

"The Company has undertaken extensive analyses of data from the Phase I portion of the Phase I/II trial of DCVax-Direct for all types of inoperable solid tumors. The Phase I portion of the study involved 3 different dose levels, 2 different product formulations, 13 different cancers, several modes of image guidance for treatment administration and multiple measures related to immune system activation. Analyses of this data have found some novel, unexpected and encouraging results that are of significance for further trials. Also, the Company and physician advisors have completed clinical analyses and preparations for injection of multiple tumors in multiple different tissue locations (going well beyond what any other known trial has undertaken), as well as a greater number of treatment cycles, for the upcoming Phase II portion of the trial. In addition, the Company and its manufacturer, Cognate BioServices, Inc. (“Cognate”) have completed a lengthy program of development work to further optimize the DCVax-Direct investigational product."

They're saying Direct P2 is going to be a whopper in my opinion. It spells out a very big way that the up to date data is fertile ground for the coming studies as well as the completion of intense development work, perhaps in the manufacturing/maturation process, so that the P2 trials will be with up to date and improved DC's and/or adjuvants.

The other part of the PR, regarding the 3 entities they're doing combo trials with is separate to the Direct P2 which is an extension of P1.

When I said it's possible that they're going to use L as one or more of the '3 separate phase II' trials I simply meant that perhaps they're already thinking about how to enhance L for GBM and even other Cancers through combinations with Checkpoint Inhibitors or other new immunotherapy agents. What if L gets approved, and right behind that comes a combo therapy that makes it even better? That's not a bad thing, and wouldn't prevent L from being approved while those trials are ongoing.

This is humongous news. The wording of the PR is unlike anything I've seen from NWBO. I can't wait to see the reaction tomorrow from Wall Street. Should be interesting if they're getting what I'm getting.