I understand historical considerations and maybe I am bemoaning a point but even CarTs were a limited audience when they were approved with safety problems which essentially limited their market to higher risk patients. L is a well established safe platform launch even though GBM is the indication being considered. Having enough space is one thing but having enough trained technicians for the artisan method is another and that is a limiting factor that demand for treatment I believe would outstrip rapidly. Even in a university setting like Cambridge it took Advent in Sawston time for available positions to be filled and a key hire came from Kings College in London where L was already being manufactured and this probably as a requirement for certification. Bottom line is it may not be a “requirement” to have more automated commercial scale manufacturing in place for approval or a journal article but it sure seems logically like a very glaring need to me that has been taken into consideration by FDA and NWBO with regard to timing things up. Even Charles River Labs added two large clean room suites at a Pennsylvania site dedicated to cell manufacturing for a vaccine candidate and a certain line of viral vectors that were also fitted out with “additional equipment” to increase capacity. In that regard comparability/equivalency studies are certainly in the advanced stages at this point both at Sawston and perhaps at Charles River Labs while both NWBO and FDA have been trickling things out for a while now making it look like a slow dance not the jive or jitterbug while catching up takes place ; ).Best wishes.
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