Our anticipated milestones
Edvince will be undergoing an active period with many value-enhancing milestones for both the parent company’s and each subsidiary.
Pre-IND application
in the USA
EMA regulatory meeting
Start of phase 2b study
Orphan Drug application in Japan (PMDA)
Orphan Drug application in India
Application for Fast Track (USA)
Application for PRIME (EU)
Interim analysis of planned phase 2b study
Compassionate Use approval for the Company’s first drug candidate EDV2209
CMC work for intravenous drug candidate for clinical studies
Agreement with clinics for clinical studies with the selected drug candidate
Contact with Ethics Committee and Medical Products Agency for approval of the study
Initiate tox/phase 1a studies
Pre-IND application (USA)
Potential PRIME application (EU)
Potential Fast Track application (USA)
In-depth discussion with Key Opinion Leaders on GI treatment
CMC work for intravenous drug candidate for human clinical trials
Initiated study planning process
Initiate tox/phase 1a studies
Investigation of Compassionate Use programme in the USA, EU and Japan
Pre-IND application (USA)
Application for Orphan Drug Designation (USA)
Application for Orphan Drug Designation (EU)
Contact
Medicon Village
223 81 Lund. Sweden
info@edvince.com