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NeoRx

Executive Summary

OncoTrac produced by Boehringer lngelheim subsidiary Dr. Karl Thomae GmbH has the same characteristics as those described in a previously filed PLA for the small cell lung cancer monoclonal antibody imaging agent, Seattle-based NeoRx announces Sept. 30. Clinical data from a small-scale study were requested by FDA after NeoRx switched manufacturers of the NR-LU-10 monoclonal antibody used in OncoTrac from lnvitron to B-1 after it had filed a PLA for the product ("The Pink Sheet" June 1, T&G-2). B-1 also must file a new Establishment License Application, which it plans to file by year end, NeoRx says. B-1 will market OncoTrac in the U.S.
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