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In Brief: Neoprobe RIGScan CR49

This article was originally published in The Gray Sheet

Executive Summary

Neoprobe RIGScan CR49: Firm plans to submit additional clinical and manufacturing information requested by FDA as an amendment to its existing biologics license application "as soon as possible." Neoprobe submitted a BLA in December 1996 for the radioimmuno-guided surgery system for detection of metastatic colon cancer ("The Gray Sheet" July 21, I&W-5). The RIGScan CR49 system consists of I125 labeled Colorectal 49 monoclonal mouse antibody and the Neoprobe 1000 radiation detection probe. Neoprobe President David Bupp notes the firm intends "to meet with the FDA at our earliest opportunity to determine the scope of the information requests"...
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