Our milestones bringing significant value to the table
Milestones
06 January 2021
ANT01 PCT PATENT
filing based on totally new and unexpected clinical relevant discoveries by inventor and owner Erik Buntinx, MD
06 January 2021
15 April 2021
Patentability of ANT01
as indicated by received International Search Report
15 April 2021
01 July 2021
Connecting the ANeuroTech Executive Team
bringing together more than 250 years of top level expertise in CNS Drug Development
01 July 2021
10 September 2021
Submission of FDA Pre-IND
Meeting Request on ANT01 in Partial Responsive Depression (PRD)
10 September 2021
22 October 2021
FDA Grant on Pre-IND Meeting
on the submitted ANT01 ⁴Pivotal Phase III Development Program in Partial Responsive Depression (PRD)
22 October 2021
19 January 2022
FDA GRANTED PIND MEETING
allowing ANT01 to enter Phase III
19 January 2022
22 February 2022
Mid 2022: Start FDA APPROVED ANT01
PIVOTAL PHASE III Development Program
22 February 2022
05 July 2022
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.
05 July 2022
24 August 2022
FDA Granted Type C COA Meeting on Anhedonia as Key Secondary Outcome for ANT-01
24 August 2022
27 October 2022
FDA Type C COA Meeting on Anhedonia Outcome for ANT-01
27 October 2022
24 April 2023
FDA IND Submission of ANT-01 Phase IIIB Development Plan
24 April 2023
23 May 2023
FDA ‘You May Proceed’ Letter for the ANT-01 Phase IIIB Development Program as Adjunctive Treatment in Major Depression
23 May 2023
First Visit First Patient (FVFP) in ANT01 Pivotal Phase IIIB Acute Efficacy Study
Q42023
Mid 2028: FDA Market Authorisation Approval
(MAA) ANT01 in PRD
