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Re: B52T38 post# 13564

Saturday, 10/13/2018 12:58:25 AM

Saturday, October 13, 2018 12:58:25 AM

Post# of 27413
Adcomm vote 10 to 3 to approve for ARCX this afternoon. PDUFA date Nov. 2 for them I think. If you can get in early Monday it could be a good score. Long term, a great score. IV morphine alternative for ER and post surgery situations. Opioid, so it needs to be tightly controlled in the current US situation. There is a morphine shortage right now, plus it does not have the overhead cost of an IV. Also already EU approved, like Cytosorb, so FDA approval could instantly boost sales overseas.
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