FDA GRANTED ANT01 PHASE IIIB STUDY PROGRAM IN PARTIAL RESPONSIVE DEPRESSION (PRD).
The emerging clinical late stage biopharmaceutical company ANEUROTECH have – as an outcome of the FDA Pre-IND Meeting on 19JAN2021 – reached out an agreement with the FDA to continue with its submitted Pivotal Phase IIIB development program on ANT01 in the higly unmet need of Partial Responsive Depression (PRD).
In meantime, ANEUROTECH has started the ANT01 PIVOTAL DEVELOPMENT PROGRAM which projects a Market Authorization in the US for PRD in H228.
Expected peak sales ranges from 1.5 up till 6 B USD due to the fast growing incidence of PRD and the lack of adequate treatment therefore.
Patent protection up to at least 2040 is expected.
- 21FEB2022: Start up of the ANT01 Phase IIIB development activities in relation to CMC, Non-Clinical and Clinical Projects.
- 18FEB2022: Final FDA Pre-IND Meeting Minutes received indicating the agreement of the FDA with the submitted ANT01 Pivotal Development Program up till Market Authorization in Partial Responsive Depression (PRD).
- 19JAN2022: Pre-IND Meeting granted by the FDA successfully addressed by its Founding CEO and Inventor, Dr. Erik Buntinx.
- 22OCT21: FDA Grant on Pre-IND Meeting on the submitted ANT01 ⁴Pivotal Phase III Development Program in Partial Responsive Depression (PRD).
- 10SEP2021: Submission of FDA Pre-IND Meeting Request on ANT01 in Partial Responsive Depression (PRD).
- 01JUL21: Connecting the ANeuroTech Executive Team, bringing together more than 250 years of top level expertise in CNS Drug Development.
- 15APR21: Patentability of ANT01 as indicated by received International Search Report
- 06JAN21: ANT01 PCT PATENT filing based on totally new and unexpected clinical relevant discoveries by inventor and owner Erik Buntinx, MD