Wright Medical's (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
really improving the ultimate odds of approval, at least suggests that
the FDA may be trying to work with the company to get Augment to market
after all.
Follow this link for more:
An Unexpected Turn In Wright Medical's Attempts To Get Augment To Market
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