Regulatory advisors appointed for BZDS1901

AdAlta has engaged Dark Horse Consulting Group Inc, sector-leading advisors, to support US FDA engagement for BZDS1901 CAR-T therapy

AdAlta CEO, Dr Tim Oldham said:

“Early engagement with the FDA is an important step in ensuring that our clinical, manufacturing and regulatory strategy for BZDS1901 is aligned with the expectations of the world’s leading regulator for cell therapies.

By engaging Dark Horse Consulting Group, Inc, we are adding highly specialised expertise with deep experience in CAR-T and cell therapy development. Their guidance will help us prepare efficiently for clinical trial approvals and position BZDS1901 to take advantage of potential regulatory pathways that could accelerate development and increase the attractiveness of the program to future partners.”