Great work TC - I surmised that Aug. 2015 is the midpoint for 113 approval taking into account that the earliest approval of a BTD drug in the FDA list took only 82 days and longest was 531 days. In essence since 113 was given BTD last month, it could be approved any month between Jan. 2015 and Mar. 2016 with Jan. 2015 reaching its 82nd day and March 2016 reaching the 531st day. Please correct me if my insinuation is wrong.
The amount of time for drug approval has, in recent years, come under scrutiny.
With respect to regenerative medicine, Japan has come up with a creative way to speed things along. The guidelines are:
1.Conditional product approvals will be based on existing Phase 2 trial results demonstrating probable efficacy and safety with bridging studies in Japanese patients
2.Conditional approvals will allow sales of each product candidate for up to 7 years
3.Conditionally approved products will be covered by health insurance
4.Conditional approvals will cover allogeneic cell therapy product candidates manufactured under GMP outside of Japan; and
5.Full approval is expected to require further confirmation of safety and efficacy in a larger population.
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