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Executive Summary

IMREG's IMREG-1 TREATMENT IND REQUEST DENIED BY FDA, the company announced May 5. Imreg said it would meet with FDA "in the near future" to discuss the protocol for a study required to demonstrate whether Imreg-1 is safe and effective. Once Imreg and FDA agree on a protocol and initiate further testing, a second Treatment IND application may be filed. Imreg's press statement declares: "Approval of a request for a Treatment protocol requires that the drug be under investigation in a controlled clinical trial, or that all necessary clinical trials have been completed." The application has been on clinical hold since last November. The Treatment IND regulations stipulate that FDA must approve or disapprove a request within 30 days. The agency placed the clinical hold on the application after referring the issues involved to an advisory committee and realizing that a recommendation would not be forthcoming within the 30-day limit. Submitted on Oct. 5, Imreg's Treatment IND request was discussed at an inconclusive meeting of FDA's Vaccines & Related Biological Products Advisory Committee on Nov. 18 and placed on clinical hold pending review of the supporting data at a second meeting of the panel. At its second meeting on Imreg-1, the committee concluded that the data indicated the biologic may be effective in controlling ARC (AIDS-related complex) but must be corroborated by further testing ("The Pink Sheet" April 10, T&G-1).

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