NorthWest Biotherapeutics Inc (NWBO)

[beartrap12]

GGBill, Several of the doctors involved in the development of DCVax have actually said that L and Direct are essentially the same treatment, but delivered differently. Who exactly said it eludes me now, but I’m sure somebody out there will provide the person(s) and maybe even the link. It may have been Dr. Bosch and Linda Powers may have repeated it..
Anyway, what you’ve suggested, that this trial is taking so long because they are trying to cover both L and Direct with the new SAP, holds some real possibility because of the comment from a doctor or two that they are “the same”.
I believe this is part of the hold up. If the regulators agree they are the same, then Direct may still require a short trial or a “label extension”. Who knows? I don’t really know what’s involved in a label extension, but I understand it’s much shorter in time than a full blown Phase II and III.
I also believe that NWBO has collected a tremendous amount of data on recurrent GBM and may be in for a shortened trial because this first one has taken so long. I believe UCLA has started that trial.
Keep in mind that Dcvax is a platform technology that already shown efficacy in ovarian cancer in a Phase I clinical trial, and other cancers through compassionate care. We believe it can be applied to all solid cancers.
And of course, we’ve seen Direct, with the proper timing, working well in several major cancers for inoperable cancers, which is the toughest of all groups to cure. And we’ve seen patients go from the doorstep of hospice to living and returning to a normal life after taking Direct.
And yes, $$$$$$ may be sooner than some naysayers would have us believe.