San Diego, CA -- (SBWIRE) -- 09/19/2012 -- An investigation on behalf of investors of Navidea Biopharmaceuticals Inc (NYSEAMEX:NAVB) shares over potential securities laws violations by Navidea Biopharmaceuticals Inc and certain of its directors and in connection with certain statements was announced.
Investors who purchased shares of Navidea Biopharmaceuticals Inc (NYSEAMEX:NAVB), have certain options and should contact the Shareholders Foundation at mail(at)shareholdersfoundation.com or call +1(858) 779 - 1554.
The investigation by a law firm focuses on possible claims on behalf of purchasers of the securities of Navidea Biopharmaceuticals Inc (NYSEAMEX:NAVB) concerning whether a series of statements by Navidea Biopharmaceuticals Inc . regarding its business, its prospects and its operations were materially false and misleading at the time they were made.
On Sep. 10, 2012, after the market closed, Navidea Biopharmaceuticals Inc (NYSEAMEX:NAVB), announced that it received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for Lymphoseek® (technetium Tc 99m tilmanocept) Injection.
Navidea Biopharmaceuticals Inc said that in the Complete Response Letter, the FDA noted the decision was focused on issues with third-party Lymphoseek contract manufacturing, and was not related to any efficacy or safety data filed within the Lymphoseek NDA.
During the conference call that followed the announcment, Navidea Biopharmaceuticals’ CEO said, in part, that: “The FDA requests arose from inspection by the FDA field office of these contract manufacturing facilities. These manufacturing facilities have worked closely with these field offices and put in place plans that they believed were adequate and deemed acceptable by the agency. So we are now going to circle back to address the remaining questions that appear to have arisen as a result of this Complete Response Letter”
Shares of Navidea Biopharmaceuticals Inc (NYSEAMEX:NAVB) fell from $3.80 per share on Monday, September 10, 2012, to $2.34 per share on Tuesday.
Those who purchased shares of Navidea Biopharmaceuticals Inc (NYSEAMEX:NAVB) and currently hold those Navidea Biopharmaceuticals Inc shares, may have certain options and should contact the Shareholders Foundation.
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