NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

exwannabe,

When I referred to the idea of "stand alone" in my previous post that was not meant to imply comparison to historical norms. This concept is based on evidence derived from other clinical trials that point to this potential with DC therapy but for the most part has been negatively impacted by slightly to moderately active "placebos", too broad of a target population and definately the pseudo effect. FDA is tied to this trial by their own insistance for a cross-over which appears to have been a blessing to those who are "living longer". Now FDA must do everything in their power to learn what the implications of this mandated cross-over means. I believe they want to verify the biomarker ties to longevity, verify a solution to the pseudo problem, want to understand potential synergy better and understand MO of DC therapy on various subtypes. I believe they are doing that right now.

Some here seem to think that FDA is so legalistic that they could care less about what is at stake for patients outside of this trial even though the trial will help them learn a great deal about the science. These folks believe this trial will ultimately fail to gain approval because of trial design flaws. I believe there is enough flexibility designed into the trial and motivation from regulators and research community now to see this through to the end. That means we will at least get to HE reimbursement as a minimum (trial fully enrolled) or better. This minimum would mean another trial but with income. Better could be up to much, much better and perhaps be more in line with the production capacity ramp up we are seeing.