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BioMimetic submits more data on bone graft product
(Reuters) - BioMimetic Therapeutics Inc said it submitted additional data sought by health regulators for the marketing approval of the company's bone graft product, sending its shares up 14 percent after the bell.
The biotechnology company said it filed an amended application saying that the bone graft product, Augment, is not inferior to autograft.
The Food and Drug Administration in January declined to approve marketing of BioMimetic's bone graft product and asked for additional safety and efficacy data from a late-stage trial.
The Franklin, Tennessee-based company expects a final decision from the regulator between April 2013 and January 2014, even if the FDA had a second round of questions.
BioMimetic shares, which have lost about 40 percent of their value so far this year, were up 14 percent at $3.19 after the bell. They closed at $2.80 on Monday on the Nasdaq.
(Reporting by Prateek Kumar in Bangalore; Editing by Don Sebastian)
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