Researchers suggest an application to FDA may be made within the next 12 months, requesting approval to carry out a human clinical trial with the gene therapy.
The patent filing expands upon data obtained from animal model testing and the istaroxime human clinical trials in acute heart failure (AHF) and early cardiogenic shock (ECS), including the latest ...
This most recent meeting with PMDA had several important outcomes,” said Peter Altman, Ph.D., BioCardia’s President and Chief Executive Officer.” First, PMDA has invited our next consultation after ...