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I found this excerpt from replicel's 3rd quarter 2013 financial report
"The company is also in the final stages of RCH-01 technology transfer to its licensed partner, Shiseido, for Japan, China and the ASEAN countries. Shiseido is developing its own program for RCH-01 in Japan. Any new improvements made to the technology by either party will be shared. In addition, the government of Japan has announced its intention to accelerate cell-based therapies through a revised regulatory process which is expected to be made public in January 2014. The new process should facilitate the initiation of Shiseido’s clinical program and, as a result, RepliCel expects to have two concurrent RCH-01 human clinical trials which will significantly increase the available human clinical data on RCH-01."
Just out of curiosity does anyone know if this "revised regulatory process" is just a way to quickly bring out a product or do they mean something else. I know Replicel's phase 2 through the FDA approval method is going to take another 3 years, hopefully in Japan they will shorten that time span. Either way I guess we'll know by January. But if someone can enlighten me that would be great too.
"The company is also in the final stages of RCH-01 technology transfer to its licensed partner, Shiseido, for Japan, China and the ASEAN countries. Shiseido is developing its own program for RCH-01 in Japan. Any new improvements made to the technology by either party will be shared. In addition, the government of Japan has announced its intention to accelerate cell-based therapies through a revised regulatory process which is expected to be made public in January 2014. The new process should facilitate the initiation of Shiseido’s clinical program and, as a result, RepliCel expects to have two concurrent RCH-01 human clinical trials which will significantly increase the available human clinical data on RCH-01."
Just out of curiosity does anyone know if this "revised regulatory process" is just a way to quickly bring out a product or do they mean something else. I know Replicel's phase 2 through the FDA approval method is going to take another 3 years, hopefully in Japan they will shorten that time span. Either way I guess we'll know by January. But if someone can enlighten me that would be great too.