AGN won't be able to combat the dosage/duration issue well unless they run a proper trial showing they can achieve longer duration at higher doses. if anything RVNC can set the record straight and explain (just like dysport) that one unit of daxi doesn't equal one unit of botox and that the dose of active toxin is actually the same. Having said that this is a narrative that AGN has propagated so RVNC has some work cut out for them once in the market
as for the biosimilar the time line does seem to have slipped a little. It could be that mylan isn't interested in opting in, but that is not all that likely based on what both companies stated after the meeting w FDA. It could be as simple as the government shutdown caused enough backlog at FDA that it took them longer than the usual 30 days to get the minutes back. A less likely but not impossible explanation could also be that they are renegotiating some terms.
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