NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

barnstormer,

I believe that transition from artisan to Flaskworks must be accounted for before approval of artisan and only is doable in a reasonable time frame with a final GMP Flaskworks model chosen and ready to move into final on site validation. Others believe this is a separate issue but then have no reasonable explanation for such a long delay to approval for a manufacturing method that has been around for a very long time which will not be able to keep up with demand from all directions once approval is granted.
Approval does not guarantee profitability either so getting Flaskworks up and running asap after approval is crucial for business success and the Class C buildout with no further plans for Class B clean rooms tells the story about meeting initial demand starting with artisan that is expected to transition quickly to Flaskworks.
Whether anyone puts emphasis on regulators wanting Flaskworks or NWBO needs to transition to be profitable, the preparation is the same. To me the delay in approval is best explained by regulator desire to have Flaskworks ready ASAP and NICE reimbursement rate being able to keep the pressure on for Flaskworks advancement. Nice has not received what they need from NWBO for reimbursement that we know of yet and if approval was based only on artisan that should have been in already. Seems reimbursement rate can only really help when Flaskworks is ready; ). Best wishes.