U.S. FDA – NDA EMA – MAA Status18 Mar 2022 10:05
Any thoughts on FDA approval (subject to manufacturing inspections), reviewing the results presentation the tone seemed quite bullish, slide 18 highlights -
"Commercial & Medical Affairs staff in place with plan to reach 84 by H2 2022 launch"
U.S. FDA – NDA Status
• Remaining clinical & manufacturing site inspections pending
• Mid- & late-cycle review meetings complete
• PDUFA is Apr 30, 2022 subject to FDA scheduling limitations
EMA – MAA Status
• Completed the 120-day assessment, & now entering the later
stages of MAA review