Neoprobe Corporation (OTCBB: NEOP), a diversified developer of innovative oncology surgical and diagnostic products, today announced that it has submitted a response letter to the U.S. Food and Drug Administration (FDA) regarding its RIGScan™ technology Biologic License Application (BLA). The filing of the BLA response letter is the initial step in Neoprobe's efforts to commercialize the RIGS® technology designed to enhance the surgical treatment of solid tumor cancers. The review responsibility for the RIGS BLA was recently transferred from the Center for Biologics Evaluation and Research (CBER) to the Division of Medical Imaging Products in the Center for Drug Evaluation and Research (CDER) at FDA.
“The submission of the BLA response letter is the first of several near-term activities that Neoprobe intends to complete with FDA to reactivate the development of the RIGS technology”
"The submission of the BLA response letter is the first of several near-term activities that Neoprobe intends to complete with FDA to reactivate the development of the RIGS technology," said Rodger Brown, Neoprobe's Vice President of Regulatory Affairs and Quality Assurance. "We intend to file a request for an Investigational New Drug (IND) for the biologic component of the RIGS technology. The IND request will be accompanied by a synopsis of the proposed Phase 3 RIGS technology clinical evaluation. Once FDA has assigned a new IND we will file the complete protocol for FDA evaluation under the provisions of a Special Protocol Assessment (SPA). A SPA review of the prospective protocol will provide a clear development pathway for RIGS in 2011."
Neoprobe executives will discuss the development activities for both the RIGS and Lymphoseek® product initiatives during the third quarter earnings conference call planned for the second week of November.
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