NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

biosectinvestor,

I agree the regulatory agencies want treatments that work made available. I believe they have already been willing to make DCVax-L available and their refusal to allow SOC/placebo into the trial after the hold is proof of this to me. The problem is the rules are not set up right yet for reimbursement rate and ascribing full benefit of the product once approval is given for a therapy that is showing improving outcomes over time due to refinements in manufacturing. The rules are changing but the rules are almost always set up to benefit the status quo as much as possible as that is where funding for many individuals connected to the regulatory agencies comes from. Slow walking the rules changes so that the "right folks" benefit is a tctic I have seen before. NWBO will prove that their refined manufacturing methods correlate strongly to final outcomes. When that is undeniable then reimbursement can be negotiated from a position of strength which is needed for manufacturing ramp up and lead in to Direct. I agree with you that NWBO is doing what it feels it must to leave no doubt. They are essentially taking any subjective decision making out of the hands of regulators by making results so clear to doctors and patients that regulators have no choice but to help move this product into other indications quickly and agree to an appropriate reimbursement rate for benefit associated more with later enrolled patients. Best wishes.