$DRRX fda.gov/media/134721/download FDA AdCom presentation slides. I think it looks good. Now listen to the AdCom votes. collaboration.fda.gov/pefc0... You need Adobe connect to listen. Go to the last session that gives the voting opinion. Listen again. The negative votes were focussing on the side effects questioning validity based on a statistician who was not happy with the data. Overall they all agree no side effects. They agree we need a narcotic sparing drug. They all agree the 24 hr with less narcotic is impressive. I believe the FDA will approve and may request post approval studies. The shorts will be fried when the FDA approves it.
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