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lax20m

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lax20m

Re: trading_cyclist post# 60183

Thursday, 02/26/2015 5:49:13 PM

Thursday, February 26, 2015 5:49:13 PM

Post# of 80490
Yes it can be approved in any phase but and NDA is required and if the company says they aren't filing one this year it won't be approved this year.

There is a chart at the bottom of this page that shows the differences in the FDA programs. All of them still require filing an NDA. The way the FDA collaborates and review times are different based on the program. Break through fastest but they just don't approve drugs without NDAs!

http://www.natap.org/2013/HCV/022213_01.htm

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