Wright Medical's (NASDAQ:WMGI) acquisition of BioMimetic Therapeutics and its Augment biological product for bone healing has been almost nothing but trouble. At seemingly every turn the FDA has thrown up obstacles to Augment, quibbling about the use of CT scanning, demanding re-readings of scans by additional radiologists, requiring antibody testing, and forcing the company to count unrelated secondary surgeries as product failures.
The end result is that the FDA has refused on multiple occasions to approve Augment, putting the $190 million acquisition (excluding potential future contingent payments) at real risk. Wright Medical isn't going down without a fight, though, having appealed the FDA's last rejection. On Monday March 10, though, a new development arose that while not...
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