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Neoprobe Corporation (NEOP) Lymphoseek Pre-NDA Meeting


10/7/2010 9:55:01 AM

DUBLIN, Ohio--(BUSINESS WIRE)--Neoprobe Corporation (OTCBB: NEOP), a diversified developer of innovative oncology surgical and diagnostic products, today announced that it has completed a pre-NDA assessment for Lymphoseek® with the U.S. Food and Drug Administration (FDA). As a result of the pre-NDA assessment, FDA has requested that data from both the completed NEO3-05 study and the NEO3-09 study currently in progress be included in the Company’s primary New Drug Application (NDA) for Lymphoseek rather than submitting the NEO3-09 study data as a major amendment to the ongoing NDA review.

Read at BioSpace.com

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