Lifecore Schedules September FDA Dispute Resolution Panel
CHASKA, Minn.--(BUSINESS WIRE)--July 18, 2001--LIFECORE BIOMEDICAL, INC. (Nasdaq:LCBM) announced today that as a result of discussions between the Company and the FDA, a meeting of the Medical Devices Dispute Resolution Panel (MDDRP) has been scheduled for September 6, 2001 in Washington, D.C. That meeting will address scientific issues that are in dispute between Lifecore and the FDA in connection with Lifecore's pending PMA application, as amended, for its ferric hyaluronan product, GYNECARE INTERGEL(a) Adhesion Prevention Solution.
In addition, the Company indicated that it has incurred sharply increased expenses associated with the ongoing regulatory issues surrounding the product dispute and the MDDRP. Primarily as a result of those increased expenses, Lifecore anticipates a loss of $0.14 to $0.17 per share for the fourth fiscal quarter ending June 30, 2001. The Company had previously indicated that it expected a loss of up to $0.09 per share for the quarter. Lifecore estimates losses will continue at a similar level through the first half of fiscal 2002.