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Re: jq1234 post# 158353

Thursday, 03/14/2013 10:52:49 PM

Thursday, March 14, 2013 10:52:49 PM

Post# of 257553
I wasn't that familiar with the EMA process till InterMune went through it. I was quite surprised when I found out they didn't do that already! I realize they can go to the sponsor and ask them to run any new analysis they want (that may come up during the review and not be part of the original submission) and it probably is part of the reason the process is slower there. Still it would seem reasonable and logical that regulatory bodies have all the data.

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