FDA missed ATXI/FBIO PDUFA target date
ATXI announced that the FDA had not reached a decision on its April 12, 2021 PDUFA for IV Tramadol. Interesting that the FDA misses another PDUFA deadline, and interesting that the market reads this as a negative. The FDA has missed more PDUFA deadlines since the pandemic struck, although ATXI's response to the CRL should not have required any site visits or activity that is most affected by the pandemic. Time to launch/sales affects valuation. Thus, from that standpoint the market reaction makes some sense. However, this particular ATXI/FBIO PDUFA, which is one of our April Big-Mover events, any upcoming product launch, and their corporate situation is complex. See our bull/bear post with details.
#PDUFA #FDA #ATXI #FBIO #Tramadol
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