Lifecore Biomedical
This article was originally published in The Gray Sheet
Executive Summary
Scuttled FDA General and Plastic Surgery Devices Panel review of the firm's Intergel anti-adhesion product will indirectly lead to a $0.09 per share loss in both the third and fourth quarter, company President and CEO Jim Bracke reports Feb. 2. The company had stocked sufficient amounts of the ferric hyaluronate-based product to accommodate an anticipated third quarter U.S. rollout, the exec explained. Addressing the panel recommendation against approval (1"The Gray Sheet" Jan. 17, p. 4), Bracke notes that panel members "were not given all information in advance," so they were unable to fairly evaluate the product. He adds that FDA has identified the additional data necessary to obtain approval and said that the agency "is not bound by the panel's recommendation." Bracke says he has "no idea" when the product could gain approval, however, analysts predict that Intergel gain market go-ahead in the next 6-12 months for use in reducing post-surgical adhesion formation after gynecological laparotomy procedures