NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

Steady_T,

The regulator decision was basically made in 2015 with the screening halt and subsequent enrollment of treatment arm only patients which left the trial in a lower powered state and yet still enrolled to the point statistically necessary as noted in the 2015 Fraunhofer annual report. NWBO has for the last 9 years been silent about the screening hold, not bought shares on the open market and financed with their own money to keep NWBO a going concern which is permitted. Les only weakly commented, as deflection, about the enrollment discrepancy which sentiment_stocks supported at the time on the message board which helped the longs and the shorts continue to be at odds so that consensus would not lead to trial data being interfered with by patients wanting to cross over early which I thought was an option at the time for those originally enrolled in SOC/placebo.
Bottom line is NWBO had a lot of hurdles yet to jump before being ready for approval and that included an MIA human designation which just happened this year AFTER the MAA had been submitted with MIA experimental designation. Are we closer to Flaskworks GMP validation now so that the business model can work for reimbursement pricing and expected rapid expansion? Manufacturing, manufacturing, manufacturing!; ). Best wishes.