Neoprobe Corp. to Meet with FDA on RIGScan CR49 Development

Neoprobe Corp., a developer of oncology and cardiovascular surgical and diagnostic products, is set to meet with the U.S. Food and Drug Administration (FDA) on April 15, 2004, to discuss the submission of additional clinical information for RIGScan CR49. The meeting aims to review procedures for completing further analysis of clinical data and outlining a possible development timeline for the product, which has been stalled due to questions raised by the FDA. The company's president and CEO, David Bupp, has acknowledged the importance of addressing the FDA's concerns and providing information on the potential survival differential for patients using RIGScan CR49.

Key Takeaways:

• Neoprobe Corp. scheduled a meeting with the FDA on April 15, 2004, to discuss the submission of additional clinical information for RIGScan CR49.
• The meeting aims to review procedures for completing further analysis of clinical data and outlining a possible development timeline for RIGScan CR49.
• The FDA raised questions related to the patient benefit of using RIGScan CR49, prompting Neoprobe to review clinical studies and consider further development.
• Neoprobe's president and CEO, David Bupp, emphasized the importance of addressing the FDA's concerns and providing information on the potential survival differential for patients using RIGScan CR49.
• RIGScan CR49 is a biologic product developed for diagnostic purposes, particularly in colorectal cancer treatment.
• Neoprobe Corp. develops and provides surgical and diagnostic products, including gamma detection systems widely used for intraoperative lymphatic mapping in breast cancer and melanoma.
• The meeting with the FDA is a critical step in reactivating the stalled development plan for RIGScan CR49.

Statistics:

• Date of the meeting: April 15, 2004
• Product under development: RIGScan CR49
• Number of gamma detection systems sold annually: Not specified
• Total revenue generated by Neoprobe's current line of gamma detection systems: Not specified
• Number of clinical studies reviewed by Neoprobe: At least some, with the potential for more
• Survival differential for patients using RIGScan CR49: Potentially significant, as per David Bupp's statement
• Number of patients evaluated with RIGScan CR49 in clinical studies: Not specified

Sources:

• NewsRx.com & NewsRx.net, 2004 MAR 29 - (NewsRx.com & NewsRx.net) -- Neoprobe Corp.
• Health & Medicine Week via NewsRx.com & NewsRx.net, Copyright 2004