Ariad Pharmaceuticals Inc fka ARIA

[micanwait]

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.

http://www.nasdaq.com/press-release/japanese-legislation-takes-effect-for-expedited-approvals-of-regenerative-medical-products-20141124-01098