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PROTEASE INHIBITOR SPONSORS KEEPING TIGHT CONTROL OVER NEW AGENTS; NIH HAS ASKED TO MOVE COMPOUNDS INTO GOVERNMENT TRIALS; ACCELERATED APPROVAL ISSUES RAISED

Executive Summary

Manufacturers of protease inhibitors are maintaining strict control over new product development despite continuing overtures from the federal government to move the compounds into NIH clinical trials. Companies have opted to concentrate on individual pivotal trials rather than become involved in government trials aimed at a broader array of ancillary questions.
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