Neoprobe presses past controversy, submits Lymphoseek NDA| Regulatory Roundup

August 11, 2011 By MassDevice staff Leave a Comment

Cancer diagnostics firm Neoprobe Corp. (NYSE Amex:NEOP) pressed past the controversy surrounding its Lymphoseek radiopharmaceutical and submitted a new drug application for FDA review.

The Dublin, Ohio-based company hopes to win clearance for Lymphoseek for use in intraoperative lymphatic mapping, a surgical procedure that identifies and biopsies lymph nodes for traces of cancer.

Neoprobe has weathered a storm of criticism, including a citizen’s petition filed by hedge fund MSMB Capital Management asking the FDA to block the new drug application the grounds that the drug’s pivotal trials suffered from vital mistakes, allegations that Neoprobe has officially rebutted.

In its formal response, Neoprobe called the citizen’s petition "baseless and replete with factual and regulatory misstatements, served under a cloak of legitimacy," and called MSMB a "short-seller who could potentially benefit financially from a decline in Neoprobe’s stock price."

"In over 500 subjects receiving Lymphoseek to date," Neoprobe wrote it a recent press release, "no drug-related serious adverse events or clinically significant drug-related adverse events have been reported."

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