I am taking clippings from several articles and am asking my question at the bottom of this post:
1. "Japan’s new regenerative medicine legislation is actually two separate laws. Law No. 84/2013 amends the Pharmaceutical Affairs Act, renamed the Pharmaceutical and Medical Device (PMD) Act, and pertains to the commercial development of regenerative therapeutics. Law 85/2013, the Safety of Regenerative Medicine Act, deals with clinical and physician-led research."
2. "This law speeds therapeutics to market by allowing conditional marketing authorization."
3. "A 20-person trial (for example) that shows safety and is predictive of efficacy is sufficient to get conditional approval for seven years, without needing placebo trials. Efficacy will be determined by the market. The new regulations dramatically change the pathway toward revenue.”
4. "Our understanding of the PMD Act is that the PMDA is looking for more than just a Phase 1-type analysis (meaning, they are looking for a Phase 2-type). It would like to see a record of safety and some meaningful evidence of therapeutic benefit"
QUESTION:
Other than the approved and currently selling TEMCELL, why hasn't Mesoblast pushed for marketing treatments in Congestive Heart Failure, Low Back Pain, Type 2 Diabetes since they have successfully completed Phase 2 trails for these?
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