jandekkers schreef op 12 augustus 2022 07:09:
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De pdufa datum is 6 maanden na 60 dagen dus ongeveer Maart 27 2023
July 29, 2022, a New Drug Application (NDA) was submitted to the US FDA for leniolisib, for the treatment of activated phosphoinositide 3-kinase delta (PI3Kd) syndrome (APDS) in adults and adolescents aged 12 or older. Aligned with the goals set out in PDUFA VI, Pharming expects a Filing Notification Letter by Day 60, which will include the FDA's determination of priority review. If priority review is granted, it is expected that the FDA review will be completed within six months of the 60-day filing date.