TSXV:TRL.H - Post by User
Comment by
LTOWNERon May 27, 2014 3:16pm
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Post# 22602592
RE:Something to take note of...
RE:Something to take note of...Excellent Pepper! Approval can be anticipated at this point!
According to this document a preliminary decision on 'action' (approval or not) is made before getting into labeling discussions, in fact well in advance of labeling.
"Adherence to the review timeline, includingcompletion of primary and secondary reviews well in advance of the PDUFA goal date, allowstime to resolve labeling content issues and avoidscrisis management of these issues near thePDUFA goal date."