Smitty5150,
The pulse of NWBO is Flaskworks manufacturing needed at true commercial scale up. Artisan was never going to scale very well for various reasons and was expected to become outdated quickly. This is why initial buildout was limited to smaller 1a and 1b zones since their suites of class B clean rooms would create very expensive to install and maintain areas that would limit longer term production capacity for L.
There is no reason to think that artisan could not have been approved sooner except that it would be almost immediately insufficient, especially as likely SOC, due to cost vs reimbursement rate and ramp up limitations. Set aside funds will run out at some point so reimbursement at that point needs to come from NICE.
From a business standpoint a reimbursement agreement needs to happen sometime between artisan approval and when set aside funds run low which is when artisan needs to have been replaced by Flaskworks. Remember that while many prospective patients were excluded in the trial for various reasons, more doses can be made with a smaller tumor sample now than was required for the trial and this increases the number of eligible patients. Matching donors will also eventually be approved for those struggling with leukopheresis and this will also increase the eligible patient population.
Those who say the timing for approval does not technically depend on Flaskworks are correct. However, I believe the company must time everything up with a NICE reimbursement rate that the company can grow with while avoiding impediments to expansion created by maintaining artisan production too long. My speculation for quite some time has been that NWBO MAA progress was held back to a significant extent by the timing for this. The bears finally came around to acknowledging this too by stating that L is too costly compared to the current SOC which is the health care equivalent of total surrender to the condition. Best wishes.
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