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Osiris announces agreement with FDA regarding Grafix, spat with Feuerstein ensues

  • Shares of Osiris Therapeutics (OSIR -17%) are having a rough session.
  • At the heart of today's weakness is a debate about the status of Grafix and Ovation which, in turn, has roots in an FDA letter sent to MidMedx (MDXG) in August regarding a distinction between HCT/P products and biologic products.
  • Around that time, The Street's Adam Feuerstein suggested the issue might end up affecting OSIR.
  • This morning, OSIR said that after discussions with the FDA, it was determined that "Grafix will remain on the market as a wound cover for the treatment of acute and chronic wounds. For certain expanded indications ... OSIR has committed to submit a Biologics License Application." (PR)
  • Feuerstein promptly published a new piece carrying the headline: "FDA slaps Osiris for misleading medical claims about stem-cell bandage."
  • A few hours later, OSIR issued a PR alleging Feuerstein "falsely claimed [that] OSIR was issued a Warning Letter from the FDA [and] falsely stated that OSIR would need to stop marketing Grafix for diabetic foot ulcers." Now, the company says it is "reviewing all of its legal and regulatory options." (PR)
Comments (1)
  • Keubiko
    , contributor
    Comments (1793) | Send Message
     
    Excerpt from FDA letter:

     

    >>None of the amniotic/chorionic-based products described in this letter are the subject of an approved biologics license application (BLA), nor are there INDs in effect for any of these products. Based on this information, we have determined that your actions have violated the Act and the PHS Act.<<

     

    >>We request that you notify this office, in writing, of the steps you have taken or will take to address the violations noted above and to prevent their recurrence.<<

     

    I suppose what OSIR is trying to say here is "we didn't technically get a Warning Letter, we just got a letter stating that we've violated two laws"

     

    No problem at all.

     

    Given OSIR received this letter on September 26, I'm not sure how it wouldn't be considered material to investors...
    21 Oct 2013, 04:05 PM Reply Like
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