Published: 15. May, 2025
The Company has advanced well with its planned activities Positive CT001 MDR assessment Finalization…
The Company has advanced well with its planned activities
Positive CT001 MDR assessment
Finalization of Paediatric Safety Study 0202
US manufacturing and launch finalization still in process
EMA submission planning process
Comment from CEO, Jes Trygved:
The positive CT001 MDR assessment was a great achievement which will be part of the EMA submission, which is planned later this year hopefully after our final reporting on Study 0202 is completed. We are still spending a significant time and effort on the manufacturing and launch. preparation of CT001 for the US market, this is another major milestone, and we hope soon to have a final launch date. We are pleased to have seen good progress with the Paediatric Safety Study 0202, that has now been closed, and data cleaning and analysis is ongoing before we can present the top-line results during May. Thanks for a great effort by the team!
Link to Report: Q1-2025 Report
