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Wednesday, December 16, 2015 10:08:15 PM
Simply based on demographics, marketing and expedited approval.
China and Japan need a solution for Alzheimer's yesterday, it's just a creeping up thing in the U.S.
IMO we could get some solid cash and nice royalties for selling rights to the Asian market. No more dilution then...
How quickly will they approve a drug they need desperately? National healthcare system is paying big bucks to take care of elderly. Good AZ drug means filial children can take care of their elders longer. Early AZ patients stay in their own home longer.
Japan beats FDA for fastest drug approvals
August 07, 2015
A new report indicates that Japan had the fastest drug approval times last year, edging out FDA. According to the report by the Centre for Innovation in Regulatory Science (CIRS), Japan's median time for approval of new active substances (NASs) was 306 days in 2014, compared with 343 for in the United States and 418 in the European Union.
A new report indicates that Japan had the fastest drug approval times last year, edging out FDA. According to the report by the Centre for Innovation in Regulatory Science (CIRS), Japan's median time for approval of new active substances (NASs) was 306 days in 2014, compared with 343 for in the United States and 418 in the European Union. Japan's median drug approval time has dropped significantly in the past decade; NASs took about 800 days to approve in 2005 and 2006. There were record numbers of NAS approvals by Japanese, FDA, and European Medicines Agency officials last year, the report found, with 52 in Japan, 45 in the United States, and 30 in the European Union. All three regulators also approved a record number of orphan drugs in 2014, with 33 approved in Japan, 24 in the United States, and 17 in the European Union.
Regulatory Focus (07/31/2015) Mezher, Michael
http://www.raps.org/Regulatory-Focus/News/2015/07/31/22952/Japan-Edges-out-FDA-for-Fastest-Approvals/
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