Neoprobe, a developer of oncology surgical and diagnostic products, has requested and been granted a Type B pre-IND meeting with the US Food and Drug Administration (FDA) regarding its RIGS technology biologic license application (BLA).
Neoprobe said the pre-IND meeting request is another step in Neoprobe’s efforts to develop and commercialise the RIGS technology designed to enhance the surgical treatment of patients with solid tumor cancers.
Neoprobe Regulatory Affairs and Quality Assurance vice president Rodger Brown said that pre-IND meeting request is one of several near-term activities that Neoprobe intends to complete with FDA to reactivate the development of the RIGS technology program.
"The FDA has confirmed a meeting date in the first quarter of 2011 and we are in the process of completing the briefing documents in preparation for this meeting," Brown said.
"Once FDA has agreed with our RIGS development plans, and has assigned a new IND, we anticipate more extensively restarting our clinical, non-clinical and CMC efforts including pursuing the possibility of obtaining a Special Protocol Assessment (SPA) for the clinical evaluation of the RIGS technology."