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mrwrn2010

06/10/16 4:09 PM

#204501 RE: no2koolaid #204490

Let's also not forget that some instant release opioids DO indeed require AdCom meetings, such as Purdue's Avridi:

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/UCM461408.pdf

So, unless we have some impending delay about to hit, we are very likely in the clear for approval and ADT labeling.