180 days to respond to petition but of course we will know FDA's position much sooner after Braeburn/Titan's meeting with them.One would think meeting already took place or is about to.
Meeting first,then an appeal by Formal Dispute Resolution (FDR) if necessary,or sponsor concedes to FDA and will attempt to follow through on resolving all issues in CRL.
Also,any dispute appeal by Braeburn/Titan has to be resolved with data already presented to FDA.
Any new data to make for Probuphine's case for approval,will not be permissable in the appeal according to regulations.New data not already in NDA is considered a reviewable action and could be added to any new NDA resubmission but an not be part of appeal process.
I can't WAIT to hear the FDA's response to the petition. This should be classic. Wonder how they will spin it. I bet the issue just a canned statement blah, blah and totally ignore the points of the petition. The only way to get this issue attention is to get it on 60 minutes - then Congress would look into it.