Sjonnie2 schreef op 17 apr 2019 om 07:47:
In het persbericht op de Kiadis website is ook nog een update gefrommeld wanneer de vragen over de outstanding issues beantwoord worden, dat is dubbel goed nieuws !:
Kiadis Business Update:
Kiadis previously submitted a marketing authorization application (MAA) to the EMA for ATIR101 which is currently under review. The Company plans to respond to the day 180 outstanding issues by the end of May 2019
, allowing for potential EU approval and launch by the end of 2019.
The global Phase 3 trial for ATIR101, CR-AIR-009, will compare ATIR101 to the post-transplant cyclophosphamide (PTCy) or 'Baltimore' protocol. Completion of enrollment and an interim analysis of the primary endpoint is expected in 2021.