Cell Therapy News/Articles, page-15030

Mesoblast receives royalties on Remestemcel sales in Japan without any proof of efficacy...
Sounds similar to me.

https://www.abc.net.au/news/2013-11-22/mesoblast-pins-hopes-on-regulation-changes/5111524
Stem cell firm Mesoblast pins hopes on Japanese regulatory change

Fri 22 Nov 2013

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.

"The Japanese legislature has, just for stem cell products, defined them in a unique category as regenerative medicine, providing that in phase-two trials it demonstrates sufficient safety signals," Mr Itescu said.

"And of course safety trials are not usually designed to statistically prove efficacy."

The change means such products might be approved for the Japanese market without having to complete "phase-three" trials.

"That's a very exciting prospect for us, it potentially shaves off several years and very large expenditures in getting our products into the Japanese market which is really the second largest mature market in the world after the United States," Mr Itescu said.