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Re: Bryce Harper post# 27132

Friday, 03/17/2017 3:10:13 PM

Friday, March 17, 2017 3:10:13 PM

Post# of 30352
These small changes typically only need to be accompanied by the necessary preclinical data plus they have patient data from europe. I don't think they need to re-submit nda for Canada. In the US, they will consider the old data but basically it's a fresh nda anyway.
My problem with them is that they never seem to deliver on their promises within the timeframe that is expected and that is why I'been out since the r/s.
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