India, April 20 -- Passage Bio (PASG) shared feedback from a recent Type C meeting with the FDA on the likely registrational pathway for PBFT02 in FTD-GRN. The FDA has indicated that a randomized controlled registrational study design is required for PBFT02 in this indication. The company noted that a randomized controlled registrational trial poses substantial ethical concerns for patients and their families as well as logistical and financial challenges. As such, it is evaluating potential next steps in the clinical development of PBFT02 in FTD-GRN and FTD-C9orf72 in the upliFT-D trial.
Passage Bio said it has initiated a review of strategic alternatives to maximize shareholder value. These strategic alternatives may include merger or ac...