- 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)
Osiris Therapeutics, Inc. (OSIR): New Analyst Report from Zacks Equity Research - Zacks Equity Research Report
at Zacks.com (Nov 12, 2014)