Neoprobe Corp. (OTCBB:NEOP) has delayed its plan to seek approval of its drug Lymphoseek after federal regulators requested a change in the application process.
The company now plans to submit its New Drug Application (NDA) in the first quarter of 2011, according to a statement. When we last heard from the Dublin, Ohio, company, it planned to submit the application during the fourth quarter of this year. The Food and Drug Administration must approve an NDA before a company is permitted to sell the associated drug in the United States.
Lymphoseek is a tracing agent that identifies cancerous lymph nodes in patients with breast cancer and melanoma.
The delay stems from an FDA request concerning an ongoing safety study of the drug. The FDA has now requested that Neoprobe include data from the safety study in its “primary” NDA. Neoprobe had previously planned on including the study data as a “major amendment” to the application, as a result of a March meeting with the agency.
Neoprobe is currently enrolling patients in the study at eight sites across the United States and hopes to complete the study in next year’s first quarter. It plans to submit the NDA shortly thereafter.
Neoprobe officials said the additional data likely would speed up the review process. “We believe the earlier than originally planned inclusion of the [safety] study data will support stronger product labeling as an outcome of a first-cycle review of the Lymphoseek NDA and may also positively impact market adoption,” CEO David Bupp said.
Neoprobe has scheduled a Thursday morning conference call to discuss issues surrounding the NDA process.
