Telesta Therapeutics Inc. (BNC)

[BioSpecialist]

REALLY then why FDA says that Telesta can file BLA on existing clinical trial data set ???????



MCNA U.S. Regulatory Update

Following several months of active dialogue with the U.S. Food and Drug Administration (FDA), concerning the most appropriate regulatory pathway for MCNA approval in the United States, Bioniche has received written guidance. This guidance provides
regulatory clarity and permits the submission of an MCNA Biological License Application (BLA) for U.S. marketing approval review based on Bioniche's existing clinical trial data set.