While the establishment of Northwest Biotherapeutics’ leukapheresis clinic is a positive step, it’s important to view it in the context of the approval process. There are several points to unpack.
First, some may see this as additional validation that approval is inevitable, i.e., NWBO wouldn’t take this step unless they believed approval was likely.
But this is really part of the GMP/CMC process. These pieces have to be in place for approval to be granted. While it may seem counterintuitive that these steps occur before approval, that’s how the process works.
A more relevant question might be: why is this being put in place over two years after submission? What else is still being addressed?
Next, even once operational, a capacity of roughly four patients per month doesn’t point to a substantial or scalable operation in its current form.
The real takeaway from the PR is this: they’re completing requirements, not signaling outcomes.
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