NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

exwannabe,

Too much subjectivity tied to a final decision at FDA especially with influence that could be tied to questions about ECAs even though they were checked down in for bias with none found. The bears really have pushed hard on this which tells me that is where big pharma influence would like their influence to gain the upper hand during any FDA consideration. I mean the mob knows that you go after the juries to avoid justice because they are the decision makers. No different with big pharma.
May 10th 2022 should have been enough to convince anyone decisively that seeking UK approval first then going to the FDA is the best route even if most don’t understand the difference between the U.S. and UK with regard to acceptance vs approvals of SAPs. The Europeans put a heavier emphasis on upfront manufacturing preparedness than the U.S. does, though, so getting that squared away first is one of the top priorities. Having manufacturing that works for business profitability when reimbursement rates are typically lower than in the U.S. is a NWBO priority.
There is also a push for closed system manufacturing due to increased risk of contamination from open processes and profitability concerns. Whether this push is more from regulators or just necessity for NWBO can be debated. What is not debatable is that this is the direction that NWBO has chosen with no other plans for artisan expansion on the table. This fact alone as well as the time involved for an approval decision points to the importance of Flaskworks manufacturing even though regulatory issues are extremely important as well with regard to reimbursement rates and hub and spoke manufacturing.
Bringing leukapheresis capacity in house also demonstrates the need for non external capacity being required for MAA approval otherwise the capacity would have likely been initially carried by outside contractors to keep up front ramp up spending down. Leuk center capacity is limited in the UK and has been for a while but has started catching up to current and anticipated need, just not fast enough. In house leuk capacity was likely a requirement for MAA approval or cash strapped NWBO would have gone a different route. This all points back to manufacturing capacity and ramp readiness for initial demand and the planned move to Flaskworks from artisan. I believe this requires that Flaskworks be far enough along in the development process for approval to occur. Leuk capacity increases when manufacturing is expected to increase. If the increase from initial readiness is being covered 3 months in advance as is often typical then today’s job postings represent a significant demand increase over and above initial demand being met elsewhere in about 3-4 months; ). Best wishes.