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Sunday, February 25, 2024 5:21:05 PM
https://nwbio.com/northwest-biotherapeutics-announces-mhra-approval-of-license-for-gmp-manufacturing-at-sawston-uk-facility/
If you take the more optimistic figure of 500 batches a year, that would be 10,000 batches annually if Sawston were built out totally for manual production. If ten EDEN's can be installed in the space of on single manual cleanroom, that would give Sawston 100,000 batches a year as their full capacity if built out the way the initial suite was. I would think that if EDEN is approved before the Sawston facility is built out, fewer but larger cleanrooms would be built that could increase the capacity, but it's doubtful without expanding the total sq. ft. available if Sawston's capacity would exceed perhaps 150,000 batches a year. While this is an impressive number, I don't believe it would meet worldwide demand in GBM alone, and certainly couldn't touch the demand if tumor agnostic use was developing rapidly. Without the EDEN, I don't see how NWBO could possibly approach the additional regulators without substantial additional manual manufacturing capability.
Please correct me if there is something wrong with what I'm saying, but if I'm right, I continue in my belief that the EDEN is the key to filing with the other regulators as it would be cost prohibitive to build a major new complex of tiny cleanrooms with plans of replacing it in a matter of months with EDEN production that could be done in larger and less expensive cleanrooms a matter of months later. If their never was an EDEN, or anything like it was conceived of, they'd have built the tiny cleanrooms, and it would be a very profitable venture, but their is an EDEN and it will be worth waiting for.
Gary
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