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KEY ANTICIPATING NITRO-DUR II APPROVAL "VERY SHORTLY,"

Executive Summary

KEY ANTICIPATING NITRO-DUR II APPROVAL "VERY SHORTLY," the company said in its third quarter preliminary earnings report on Nov. 14. "We are most encouraged by recent indications from the FDA that all of the substantive technical issues raised by the agency have now been resolved," Key President Michael Jaharis said. "Further, yesterday we submitted to the FDA final printed labeling, which is customarily the concluding step in the approval process. Consequently, although we cannot be certain what the FDA's timing on this matter will be, we believe that approval of this important new product will be forthcoming very shortly." Key noted that current Nitro-Dur sales are being hurt due to lower trade stocking levels in anticipation of the availability of the second generation transdermal nitroglycerin patch. Jaharis indicated that Key may reevaluate continuation of its original Nitro-Dur line depending on the success and timing of the firm's Nitro-Dur II line. Noting that Key has conducted product preference studies with physicians and patients familiar with transdermal nitroglycerin patches, Jaharis said that the studies "demonstrated an overwhelming preference for our new product ]and[ provide a strong basis for believing that our new system will rapidly achieve the dominant share of the market." Jaharis added that due to the study results and "other input," Key has begun to "reevaluate the outlook for the Nitro-Dur line." The Key exec said "it is possible that the success of the new system "could require a one time downward adjustment in the book value of our existing Nitro-Dur assets."
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