Our milestones bringing significant value to the table
Milestones
ANT01 PCT PATENT
filing based on totally new and unexpected clinical relevant discoveries by inventor and owner Erik Buntinx, MD
Patentability of ANT01
as indicated by received International Search Report
Connecting the ANeuroTech Executive Team
bringing together more than 250 years of top level expertise in CNS Drug Development
Submission of FDA Pre-IND
Meeting Request on ANT01 in Partial Responsive Depression (PRD)
FDA Grant on Pre-IND Meeting
on the submitted ANT01 ⁴Pivotal Phase III Development Program in Partial Responsive Depression (PRD)
FDA GRANTED PIND MEETING
allowing ANT01 to enter Phase III
Mid 2022: Start FDA APPROVED ANT01
PIVOTAL PHASE III Development Program
Positive Feed-Back of FDA on ANT-01
Positive Feed-Back of FDA on ANT-01 Target Product Profile in Major Depression and Subjective Cognitive Decline.
FDA Granted Type C COA Meeting on Anhedonia as Key Secondary Outcome for ANT-01
FDA Type C COA Meeting on Anhedonia Outcome for ANT-01
FDA IND Submission of ANT-01 Phase IIIB Development Plan
FDA ‘You May Proceed’ Letter for the ANT-01 Phase IIIB Development Program as Adjunctive Treatment in Major Depression
First Visit First Patient (FVFP) in ANT01 Pivotal Phase IIIB Acute Efficacy Study
Q42023
Mid 2028: FDA Market Authorisation Approval
(MAA) ANT01 in PRD