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Update on Augment® Bone Graft (4/29/15)

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Enterprising Investor Member Level  Wednesday, 04/29/15 10:57:48 PM
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Update on Augment® Bone Graft (4/29/15)
The Company previously announced that an Augment® Bone Graft vendor received a Form 483 at completion of an FDA pre-approval facility inspection, which occurred in January of 2015. Late in March 2015, the vendor was notified by the FDA that its facility will be reinspected and must be in substantial compliance with the current Good Manufacturing Practice (cGMP) regulation as a condition for approval of the Augment® Bone Graft Premarket Approval Application (PMA). The Company has notified FDA that the vendor is prepared for the reinspection and asked that it be scheduled on or after May 4, 2015. Assuming a satisfactory inspection result, the Company believes final approval of Augment® Bone Graft now appears more likely in the second half of 2015.


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