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IMMEDIATE
RELEASE
CONTACTS:
Brent
Larson,
Vice
President / CFO
614
822 2330
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July
16, 2010
Gene
Marbach
Makovsky
+ Company
212
508 9645
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·
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Completion
of NEO3-05 Phase 3 Lymphoseek®
clinical evaluation in subjects with breast cancer or
melanoma;
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·
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Assessment
of final clinical data that the NEO3-05 clinical study achieved its
primary efficacy endpoint and achieved positive results related to the
secondary endpoints, including the finding of pathology-confirmed disease
in lymph node tissue;
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·
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Completion
of a successful meeting with FDA to review the NEO3-05 Phase 3 clinical
study results and discussion of development plans to support a New Drug
Application (NDA) submission for Lymphoseek as a lymphatic tissue tracing
agent;
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·
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Submission
of a draft Phase 3 clinical study protocol for RIGScan™ CR (NEO2-17) for
treatment of colorectal cancer to FDA under the provisions of a Special
Protocol Assessment (SPA);
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·
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Validation
of the first lot of Lymphoseek commercial drug product for commercial
launch in the United States upon NDA
clearance;
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·
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Introduction
of high-energy and wireless laparoscopic probes for our gamma detection
device systems;
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·
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Completion
of successful pre-NDA dialogue with FDA on Lymphoseek pre-clinical
data;
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·
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Completion
of successful pre-NDA dialogue with FDA on Lymphoseek chemistry,
manufacturing and control data;
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·
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Election
of two new Directors to Neoprobe’s Board, bringing significant drug and
medical product industry expertise;
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·
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Completion
of exchange transactions that effectively converted all of the Company’s
outstanding debt to equity;
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·
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Preparation
of the NDA for Lymphoseek well
underway;
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·
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Initiation
of the second and third Phase 3 Lymphoseek clinical studies in patients
with head and neck squamous cell carcinoma and with breast cancer or
melanoma, respectively, to support expanded post-marketing product
labeling; and
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·
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Achieved
revenue increases of 25% in 2009 over 2008 and an increase of 18% for the
first six months of 2010 over the same period in
2009.
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Conference
Call Information
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Date:
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July
19, 2010
4:00
PM ET
(877)
407-8033
(201)
689-8033
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July
26, 2010
(877)
660-6853
(201)
612-7415
286
353735
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