Memories of the AdCom meeting, do others see it the same way?
I seem to recall several who voted against approval said that the company had done everything the agency had asked of it and that there was nothing that made the medication more susceptible to abuse than others in its class. But still they voted against. And I remember that the chair of the panel actually abstained from voting, which is probably unusual. And then I remember Rapaport's comments that several have remarked on. All of this makes me wonder if the agency realizes that people were voting not on the merits of the medication being worthy of approval but about the whole issue of drug use and abuse, which was not the committee's mandate. And this makes somewhat hopeful that we have a decent chance for approval. What do you think?
I think it gets approved. The fda clearly wasnt on the same page as the panel. However i fear that the panels decision as well as dea trying to get more restrictions might put pressure on fda to denyfind a way to deny zohydro, at least temporarily