A change in Japanese regulations allowed treatments that have a satisfactory safety profile to be marketed even if the efficacy has not been verified.
"Mesoblast chief executive and founder Professor Silviu Itescu told Inside Business the bills enable Japan's government to approve new products conditionally, providing their safety is confirmed in clinical trials, even if their efficacy has not yet been verified."
So the continual claims from some posters that because it is sold in Japan it must be proven to work are completely false
https://www.abc.net.au/news/2013-11-22/mesoblast-pins-hopes-on-regulation-changes/5111524
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