ahp123,
You do realize, I hope, that the real big expansion at Memphis was planned for 2023 in the development plan from 2020. Memphis is still getting ready for commercializtion with employee hires and it was only AFTER likely unblinding to NWBO in late 2020 that expansion in earnest began all out and round the clock at Sawston and then ASAP by Cognate then CRL at Memphis. Do you really think demand could be met by artisan methods when simply adding Poly ICLC might increase GBM survival to 50% 5-7 year survival?; ). IMPOSSIBLE. Demand in GBM will be immediate and would overwhelm artisan methods because of the number of trained techs that would be required. Add in demand from off label prescriptions and from trials in other indications and the need for closed system and Edens is rather obvious and would not be overlooked by FDA even if message board posters are prone to do so.
The cost for use in other trials could be prohibitive except for the biggest pharmas in many cases but biomarker use will likely be used to help identify responders prospectively thus keeping the number of patients needed in a given trial to a much lower number to achieve statistical significance so that even smaller companies might have a chance. Streamlining is good. Best wishes.
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