Each day, more than a dozen clerks rustle through stacks of patient records as they photocopy, compile, and review an estimated 28,000 documents. The documents record data from clinical testing of what could, if approved by the FDA, be a new treatment for AIDS patients. The clerks are part of a small, highly motivated team employed by Imreg Inc., New Orleans. The tiny company is heatedly engaged in filing a new drug application for its promising Imreg-1, a therapeutic that is thought to impede progression from AIDS-related complex to AIDS. When the clerks are done, when the scientists sign off, Imreg will submit its all-important final report to the FDA.
According to a statement issued by the company, the results of phase III clinical trials show that patients with AIDS-related complex who received a placebo were five times more likely to progress to AIDS than similar patients treated with doses ...
