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Executive Summary

IMREG's TREATMENT IND REQUEST FOR ANTI-AIDS DRUG IMREG-1 is expected to be reviewed by FDA's Vaccines and Related Biologicals Advisory Committee at a meeting tentatively scheduled for April 7. The April meeting will be the second opportunity for the advisory committee to review Imreg's Treatment IND application. The committee heard contradictory presentations from FDA and the company at a Nov. 18 meeting. The agency presentations indicated that the Imreg data fail to provide evidence of the efficacy of Imreg-1 in preventing AIDS-related complex from progressing to AIDS. At the request of Imreg, the committee deferred making a recommendation on the application so that the firm could evaluate and respond to FDA's analyses of the data ("The Pink Sheet" Nov. 21, p. 3). The company recently received a complete set of FDA's analyses and presumably has prepared counterarguments for review by the advisory committee. FDA advisory committees do not usually defer recommendations to allow drug sponsors to prepare rebuttals. However, the November meeting was the first in which an advisory committee was asked to consider a Treatment IND application. FDA was under the Treatment IND regulation's 30-day time deadline to approve or disapprove the request; consequently, it had sent the committee an information package only a few days in advance of the meeting. The committee acknowledged at the meeting that it felt unprepared to render a formal recommendation. Since then, on Nov. 22, FDA placed a clinical hold on the Treatment IND protocol and eliminated the regulatory time constraint ("The Pink Sheet" Dec. 5, T&G-5). In January, Center for Biologics Evaluation and Research Director Paul Parkman, MD, reportedly sent Imreg President Arthur Gottlieb, MD, a three-page letter detailing the reasons why FDA had concluded that the company's data do not demonstrate the efficacy of Imreg-1. The agency has said its concerns with the application include the manufacture, characterization, and consistency of the product and the design and execution of the clinical trial.(ITEM 200)#050928M001J59307# #970804M001XFCWP5# (ITEM 201)(COPYRIGHT) 1989 F-D-C Reports, Inc., The Pink Sheet, February 20, 1989

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