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Re: trading_cyclist post# 60185

Thursday, 02/26/2015 5:57:33 PM

Thursday, February 26, 2015 5:57:33 PM

Post# of 80490
They need to file an NDA. The BTD allows them to work more closely with the FDA through all aspects of the process and also the FDA will review data thoruhgout the trial rather than all at once with the submission. This decreases the time to approval but doesn't alleviate the requirement for a New Drug Application. They must file an NDA.

Also no I don't believe everything the company says but if they say they are going to file an NDA in 2016 why would anyone think they were going to file substantially sooner? Sure the date could move up with positive developments. Maybe a quarter or even two but they aren't filing this year. Absent a development that's not happening so telling people on this board that the drug may be approved in 2015 is just not true.

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