Shots:

• The EC has granted ODD for PBKR03 for the treatment of Krabbe disease. The ODD was based on an EMA’s COMP positive opinion
• The designation provides potential benefits to the company- which include clinical protocol assistance- reduced regulatory fees- research grants- and up to 10 years of market exclusivity following regulatory approval
• The company plans to initiate a P-I/II GALax-C trial for PBKR03 in H1’ 21. Additionally- PBKR03 previously has received FT- ODD- RPDD for the same treatment

  Ref: Passage Bio | Image: The Pharma Letter