Osiris Legal Team Responds, Says Reviewing All of Legal-Regulatory Options, Calls TheStreet Story 'Misleading'
Earlier today, Osiris Therapeutics, Inc. (NASDAQ: OSIR), announced that it has reached agreement with the United States Food and Drug Administration (FDA) regarding the regulatory pathway for its Biosurgery products, Grafix^® and Ovation^®. In its press release regarding this agreement, Osiris addressed the recent concerns raised with respect to the regulatory status of Ovation and Grafix.
Following Osiris' release, The Street.com, through its correspondent, Adam Feuerstein, issued an article late this morning that contained material factual misstatements relating to Osiris' recent announcement. Among other things, Mr. Feuerstein falsely claimed that Osiris Therapeutics was issued a “Warning Letter” from the FDA. Furthermore, Mr. Feuerstein falsely stated that Osiris would need to stop marketing Grafix for diabetic foot ulcers. Both statements are wholly false and fundamentally misstate the nature of the agreement Osiris and the FDA have reached regarding these matters. The correspondence to which the story referred was an “Untitled Letter” which FDA uses as a mechanism for initial correspondence that does not meet the standard for regulatory significance.
Osiris is reviewing all of its legal and regulatory options with respect to the reckless and wholly erroneous The Street.com report.
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