FYI - Following discussions with regulators, JCR have discontinued development of Temcell for Epidermolysis Bullosa (due to need to for complex clinical trials/cost) - https://ssl4.eir-parts.net/doc/4552/tdnet/1942253/00.pdf
Announcement reads as if JCR were looking to get a label extension via demonstration of proof of concept in mice (and presumably other animal models) whereas the regulator was insisting on clinical trial/s
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