NEOP - will continue looking, but here is some info from the last 10K:
Our efforts in 2010 resulted in the following milestone achievements:
· Completed a successful meeting with the United States Food and Drug Administration (FDA) to review the Phase 3 (NEO3-05)
clinical study results and development plan discussion to support a New Drug Application (NDA) submission for Lymphoseek as a
lymphatic tissue tracing agent;
· Completed a successful pre-NDA dialogue with FDA on Lymphoseek pre-clinical data;
· Completed a successful pre-NDA dialogue with FDA on Lymphoseek chemistry, manufacturing and control data;
· Initiated a third Lymphoseek Phase 3 clinical study in subjects with breast cancer or melanoma (NEO3-09) to support the NDA
filing with the potential to expand Lymphoseek’s product labeling;
· Completed a pre-NDA meeting for Lymphoseek clarifying the regulatory pathway for Lymphoseek approval;
· Elected two new directors to Neoprobe’s Board, bringing significant drug industry and corporate development expertise to the
Company’s leadership;
· Completed transactions that converted all of the Company’s outstanding debt to equity;
· Received notice of grant awards of over $1.2 million to support future Lymphoseek development through non-dilutive funding;
Filed a shelf registration on Form S-3 to allow the Company to raise capital as necessary through the sale of up to $20 million in a
primary offering of securities to provide us with additional financial planning flexibility and to support the diversification of our
share ownership to new institutions;
· Completed an offering and sale of common stock and warrants under the shelf registration statement resulting in approximately
$5.5 million in net proceeds to the Company and the potential for an additional $7.0 million in proceeds from the cash-only
exercise of the warrants included in the placement;
· Completed preliminary RIGS ® development activities including transfer of the biologic license application (BLA) 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 and preparation of aninvestigational new drug (IND) request for the biologic product; and
· Filed a complete response to the open BLA for RIGScan.
