NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

learningcurve2020,

Now you know why I despise “the process” so much. Regulators (think FDA for the crossover and product release being more European issues) helped create the mess that they had no quick guaranteed green light remedy for that only an indeterminate “process” that ends with a subjective decision by FDA and need for pre approved manufacturing in Europe could solve. So no, there is nothing that NWBO could have done or said other than what they did to explain the situation they were in with no given assurances moving forward. Even this did not keep the price down as you claim when the Flaskworks acquisition and data lock occurred. This is because the SAP had been “accepted” by FDA and “approved” by MHRA and the others which obviously came before submission to MHRA and gave investors reason to believe that progress towards approval was being made.
The current issue has most certainly been about manufacturing and the likely need for side by side artisan and Flaskworks system comparisons and Flaskworks development progress so that eventual access to cancer patients after approval is not bottlenecked by capacity due to process or supply chain limitations. The discussion about these issues has been good recently on this board and explains my thinking as well.
Bottom line is access could have been made sooner and should have been made sooner with an agreed reimbursement price for artisan manufacturing that would have granted many more otherwise terminally ill patients an opportunity at extended life or a cure instead of the SOC reality that patients have been almost entirely left with. The year 2012 is when there was sufficient evidence to support granting terminal patients access to this treatment in at least a lottery style basis and that never happened even though the Specials Program at least gave those who could get funds raised a chance.
I am happy to see that some of the regulator moves in the UK and US are finally taking what NWBO and others have gone through to get to this point into account about how future promising treatments will be handled. This bodes well for Direct and other promising treatments getting to some current and future patients much sooner than otherwise would have been the case in the past in my view but is more than a decade overdue with millions of patients no longer with us because of delays caused by “the process” that has been entrenched for so long by those most able to benefit financially. I think you know that. Best wishes.