You don't understand. Shiseido already have the technology as well as the exclusive right to commercialise in Japan, with or without "approval" from Replicel. Replicel have already sold it to them and Shiseido have already received the training and everything else they need. Replicel is out of the picture now besides the dispute regarding royalties if Shiseido do decide to commercialise.
Its weird since they have a whole co-development agreement, and all that shiseido is providing with in Japan at this point is funding and manufacturing, its the Japanese hospitals that does the research.
Like its stated here.
"While Shiseido's manufacturing facility is certified by the Japanese PMDA, the clinical study is hospital-initiated and governed which means that Shiseido's role in the trial is restricted to funding and manufacturing. Any eventual commercialization of the product in Japan as a result of this study would be done as a treatment provided in partnership with hospitals under the authority of the Ministry of Health, Labor and Welfare and its Act on the Safety of Regenerative Medicine.
"The pathway under which Shiseido has decided to conduct clinical investigation of RCH-01 in Japan means the product may be the subject of early commercialization in Japan," stated RepliCel's President and Chief Executive Officer, R. Lee Buckler "While we are unclear how the clinical strategy Shiseido is pursuing may impact the product's commercialization in their markets, we remain supportive of Shiseido's decisions," continued Buckler."
Also that Replicel uses those research results for other markets around the world, so Replicel isn't out of the pictures. They are quite much IN the picture. They also establish a joint steering committee with shiseido.
