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Friday, Sep 6
Trouble may be brewing for Osiris after MiMedx FDA letter: Feuerstein
- MiMedx's (MDXG) recent issues with the FDA "might portend trouble" for Osiris Therapeutics (OSIR), theStreet's Adam Feuerstein writes, in response to a reader's e-mail inquiry.
- MDXG "believed it could sell AmnioFix and EpiFix as HCT/P products" but the FDA apparently considers them to be "biologic products" which means they "must undergo review for efficacy and safety just like other drugs," Feuerstein says.
- The problem for OSIR: "Grafix and Ovation are HCT/P products [and] MDXG is raising a stink about competitors, insisting FDA take a closer look at their products which may also violate the HCT/P manufacturing guidelines."
- A little less than a month ago, OSIR shares took off after Grafix performed well in a study of patients with diabetic foot ulcers.