Starting from 1 November 2014, companies will be allowed to apply for conditional marketing approval in Japan. The key requirement, for companies from all around the world willing to benefit from this accelerated path to market, is to provide data from a clinical study predicting likely efficacy and confirm short-time safety.
http://www.totalbiopharma.com/2014/...apans-new-legislation-will-companies-benefit/
Listening to last months webcast there was some mention about November 2014 and the regulatory framework for Japan being clearly outlined by the authorities.
Outside of the JCR alliance , MSB have had 12 months to prepare for the start date of new Japan regulations...I'm thinking the team at Meso would be aware of this date.
Could be one of the major turning points in the company.
My opinion only. Please DYOR.
Good luck to all holders.
Starting from 1 November 2014, companies will be allowed to...
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