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Thursday, October 30, 2014 6:45:56 PM
The bill, which would likely be introduced next month, would add Ebola to the FDA’s priority review voucher program, which Congress established in 2007 to encourage development of new medicines for tropical diseases. Ebola is currently not on that list.
Here’s how the voucher system currently works:: A drug maker that develops a treatment for a qualifying tropical disease receives a voucher for an FDA priority view for another medicine, which means the agency would be obligated to review the medicine in six months instead of the standard 10 months.
http://m.wsj.com/articles/BL-270B-922
This could either be sold:
A drug maker also has the option to sell a voucher. Last July, Regeneron Pharmaceuticals and Sanofi paid $67.5 million to BioMarin Pharmaceuticals for a voucher they are using to obtain faster FDA approval of a new type of cholesterol drug. The drug makers are in a race with Amgen in this market. We should note, however, that this particular voucher was awarded under a similar program for pediatric drugs, which can be redeemed sooner than tropical disease vouchers.
Or used for our TKM-HBV
Is anyone else as excited as I am for this?!!! Especially with TKM-EBOLAs new formula coming out in December right after this bill is introduced??? I'm loading the F$&K up!!!!!
IMO
GLTA
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