Lymphoseek tilmanocept regulatory update

Neoprobe filed a formal response to a June 2 Citizen's Petition submitted by hedge fund MSMB Capital Management asking FDA to deny a review and approval of an NDA for the biotech's Lymphoseek to perform intraoperative lymph node mapping. Neoprobe said the petition is "baseless and replete with factual and regulatory misstatements." The company said the petition mischaracterized the intended indication of Lymphoseek as sentinel lymph node mapping and noted its regulatory-appropriate clinical trials were designed for anatomical delineation of lymphatic tissue, for which Neoprobe plans to submit an NDA next quarter (see BioCentury, June 13). ...