Pluristem (PSTI +2.5%) says the FDA has acknowledged that aplastic anemia is a rare disease,...


Pluristem (PSTI +2.5%) says the FDA has acknowledged that aplastic anemia is a rare disease, confirming that potential treatments for the condition are eligible for orphan drug status. However, it also has requested that PSTI provide additional information and data for further analysis before the agency can determine if PLX cells can qualify for orphan drug designation for aplastic anemia. PSTI is focusing on the use of the cells to treat systemic diseases eliminate the need to use the intravenous route.

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Comments (3)
  • willg101
    , contributor
    Comment (1) | Send Message
     
    The FDA is a big tease...
    21 Nov 2012, 01:21 PM Reply Like
  • garygallen
    , contributor
    Comments (2) | Send Message
     
    The FDA is under staffed.
    21 Nov 2012, 06:18 PM Reply Like
  • Scrying Biotech
    , contributor
    Comments (2746) | Send Message
     
    I like the FDA is game. I wanna play...

     

    The FDA is reasonably cautious.
    9 Dec 2012, 06:25 AM Reply Like
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