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Re: None

Wednesday, 08/06/2014 2:39:40 PM

Wednesday, August 06, 2014 2:39:40 PM

Post# of 426508
FDA never - and will not - put back on the table any SPA for a FINISHED STUDY. btw: usually the Sponsor request the change of the SPA BEFORE START OF OR DURING the study and FDA agree or not)

FDA never - and will not - put back on the table any sNDA if they would like to approve it.

The only thing that could be on the table is Indication / label for negotiation and it's the part of the normal proccess.
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