March 7, 2016 9:39am

The envelope arrived but, the full determination is still to the future - the FDA provided a PDUFA (Prescription Drug User Fee Act) goal date of January 3, 2017.  


 

 

The U.S. Food and Drug Administration has accepted for filing its recently submitted Biologics License Application (BLA) for MACI™ (matrix applied characterized autologous cultured chondrocytes), VCEL's investigational autologous cellular product intended for the treatment of symptomatic cartilage defects of the knee in adult patients.  

 

The Bottom Line: Don't, get me wrong - it is definetely a positive with timing considerations! In addition, the FDA communicated that it is not currently planning to hold an advisory committee meeting to discuss the application.

MACI (matrix applied characterized autologous cultured chondrocytes) is a third-generation autologous chondrocyte implant (ACI) product intended for the treatment of symptomatic cartilage defects of the knee in adult patients.  MACI is an autologous implant consisting of autologous cultured chondrocytes seeded onto a resorbable Type I/III collagen membrane. Autologous cultured chondrocytes are human-derived cells which are obtained from the patient's own cartilage for the manufacture of MACI.

VCEL closed <on Friday> at $1.97 ...

Who should be worried is ... Histogenics (HSGX).