Replies to post #827718 on NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

brazen22,

We all should know by now that the biggest issue is cost vs expected demand and that meeting initial demand requires significant upfront cash outlay just for manufacturing of vaccines alone. Pretty obvious by the length of time the MAA has taken that regulators want this treatment but the manufacturing for the numbers from expected demand simply does not exist due to cost, physical limitations of artisan method and, the business model NWBO needs in order to be a viable supplier of the vaccine. In my opinion, everyone has been buying time for Flaskworks positioning and that includes any mention of potential stalling for final ECA guidance to be put in writing. Forget about any argument about starting with artisan because that is a given but ramp up has been being planned for with Flaskworks.
Bottom line is that if initial demand ramp up must be met with artisan because Flaskworks is not ready then Class C clean room space gets put on hold and CDMO manufacturing space must be acquired. This does not solve cost issues so operating with expected losses or at least initial negative cash flow for a period of time becomes necessary.
If initial expansion will still be with Flaskworks but plans now involve others with regard to a partnership or other then moving to another CDMO might make sense due to partnership considerations which takes the burden off of NWBO for meeting initial demand.
All of this is speculation about possible direction and interest (validated by length of time under consideration) by all for a new treatment for GBM, rGBM and beyond. I don’t see any impossible impediments or treatment access killing issues being considered unresolvable. I see time being utilized to help resolve issues all parties have an interest in based on the best current approval process structure available for their situations before offering the treatment to patients. “The process” stinks and needs changing for the sake of patients and innovators seeking to bring better treatments to patients sooner. The status quo resists at every turn which leaves us where we are when there is not a nearly unlimited supply of money in favor of beneficial treatment change but more than enough opposed to it. As such, the only way to win is to find a way to outlast the opponents and that takes time. Best wishes.