Achieved over the last months

Anticipated in the next 12 months


  • Early Access Program (EAP) authorization in Brazil in February 2022
  • Early termination of patient enrolment in April 2022
  • Very promising results in November 2022
  • Positive final results in February 2023
  • Launch of Early Access programs in France and Brazil
  • Application for conditional marketing authorisation in Europe and Emergency Use Authorisation (EUA) in the US


  • Positive topline study results in August 2021
  • Full study results communicated during ICFSR in September 2021
  • Submission of files to regulatory agencies (FDA, EMA) for authorization to start Phase 3
  • Start of Phase 3 study with 1st patient enrolled


  • US and Belgian IND regulatory approvals in Q1 2020
  • Clinical batch production in 2021
  • Submission of an amended protocol to regulatory agencies (FDA, EMA)
  • Start of Phase 1/2 study