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Biotech / Medical : IMNR - Immune Response
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To: Manny Gugliuzza who wrote (288)3/18/1998 1:34:00 PM
From: Easy Mark  Read Replies (1) of 1510
 
The important issue is not efficiency or cost of goods sold. The issue is providing rock solid evidence that their production process is safe, reliable, and has quality control. Without that evidence, FDA could approve Remune but hold up distribution. IRC's existing production capability (even with 50% efficiency) is sufficient to supply a large fraction of the US AIDS population. The steps taken now to provide quality assurance are vital to ensuring that production capability produces revenue in 1999. It is comforting to see work proceeding on schedule to demonstrate quality control. It is also comforting that IRC has not taken the premature step of issuing a press release regarding their quality control procedures.
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