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Executive Summary

IMREG's IMREG-1 TREATMENT IND PROTOCOL PLACED ON CLINICAL HOLD by FDA, the company disclosed in a Nov. 29 press release. Imreg said it "received notification from FDA that its treatment protocol submission (Treatment IND) is being placed on clinical hold pending submission by the company of additional clarifying information and review of this data" by the FDA staff and the agency's Vaccines and Related Biological Products Advisory Committee. FDA "indicated that it encouraged an expeditious resolution of the outstanding issues," Imreg added. The clinical hold affects only the proposed treatment protocol and effectively relieves FDA of any regulatory time limits in reviewing the Treatment IND. The clinical hold does not affect the approximately 70 patients currently receiving Imreg-1 under Imreg's standard IND exemption. On Nov. 18, the FDA advisory committee deferred a decision on the Imreg-1 Treatment IND. The committee agreed that more time was required to review the company's data and the agency's analysis and for Imreg to prepare an answer to FDA concerns ("The Pink Sheet" Nov. 21, p. 3). FDA usually sends materials to advisory committee members weeks in advance of scheduled meetings. Constrained by its 30-day time limit for Treatment IND reviews, FDA sent the committee information on Imreg-1 just three days before the meeting. In a Nov. 21 press statement, Imreg said it considered the agency analysis "seriously flawed" but would "work in a constructive manner" with FDA and the advisory committee ("The Pink Sheet" Nov. 28, T&G-8).

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