Wil Helmus schreef op 19 november 2018 10:16:
Persbericht van 6 november:
The CAPA has now been submitted to the FDA by the contract manufacturer. As a result of these efforts, Acacia Pharma has resubmitted the NDA for BARHEMSYS. Within 30 days of resubmission
FDA will classify it as either Class 1 (review completed within two months of receipt) or Class 2 (review completed within six months of receipt). Further updates in relation to these events will be provided in due course.
Uiterlijk 6 december bericht dus