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Neoprobe Planning RIGS Colorectal Cancer Detection Phase III Trial With FDA

This article was originally published in The Gray Sheet

Executive Summary

Neoprobe will meet with FDA in late summer to discuss a proposed Phase III trial protocol for its RIGS technology for colorectal cancer detection

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Neoprobe/USSC: Firms terminate marketing agreement for Neoprobe's RIGS surgical cancer detection/lymphatic mapping products. Neoprobe and U.S. Surgical Corp. co-developed the technology under a September 1996 agreement which called for USSC to pay the majority of a $5.5 mil. investment to Neoprobe upon U.S. and European approval of the first product, the RIGScan CR49 for colorectal cancer detection, in exchange for receiving exclusive worldwide sales rights (excluding Korea, Thailand, Taiwan and Singapore). A biologics licensing application for the RIGScan CR49, submitted by Neoprobe last December, has yet to be approved by FDA ("The Gray Sheet" July 21, I&W-5)...

NEOPROBE RIGSCAN CR49 BIOLOGIC APPLICATION TO BE SUBMITTED IN 45-60 DAYS, FIRM SAYS; SYSTEM DETECTS 21% MORE TUMORS IN METASTATIC COLORECTAL CANCER

Neoprobe expects to submit a biologic licensing application for its RIGScan CR49 for the detection of metastatic colorectal cancer within the next 45-60 days, the company says.

Partisan Politics Returns To US FDA Congressional Oversight

The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous and divided Congress. A House hearing, however, may be a sign that those days are over.

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