Replies to post #599782 on NorthWest Biotherapeutics Inc (NWBO)

[ATLnsider]

dmb2, are you completely ruling out the possibility of the regulatory authorities approving DCVax-L on a tissue agnostic basis now, because of: (1) its non-toxic and excellent safety record. As of result, it will not harm cancer patients, but it probably will benefit most cancer patients; (2) it’s mechanism of action (MOA) of using the patient’s own dendritic cells, pulsed with the patient’s own tumor lysate (regardless of which organ(s) the tumor(s) is/are located), to activate T Cells to find, destroy and continue to fight the cancer tumor(s). This MOA is not just specific to the brain, but should work for every organ in the human body.

Then, require NWBio to complete post-approval Phase IV, confirmatory basket trials to validate the efficacy results, and to keep the tissue-agnostic approvals?

[Doc logic]

dmb2,

I agree that NWBO is in an interesting position because there is the ovarian cancer trial, the Direct Phase 1 trial, the dendritic cell is a dendritic cell mantra and multiple preclinical trials and other clinical trials as well as compassionate use of L outside of GBM that all validate the safe use of DC therapy in multiple tumor types.
Your background is in manufacturing so you know that if there was no big picture involved the likelihood that we would have had an approval by now if planning an extended period of artisan method manufacturing would have come first. I think this is a big picture moment that regulators and others are still trying to wrap their heads around. Best wishes.