Neoprobe Corp. (NYSE:NEOP) responded to a citizen petition sent to the U.S. Food & Drug Administration today, defending clinical trials of its Lymphoseek radiopharmaceutical.
MSMB Capital Management submitted the petition asking the FDA to block Neoprobe’s application on the grounds that the drug’s pivotal trials suffered from vital mistakes.
Among the allegations are that the trials were not adequately controlled and contained conflicts of interest that may have compromised the integrity of the findings.
"Approving or considering approval of Lymphoseek would result in substantial danger to cancer patients in the U.S.," the MSMB petition says.
Neoprobe reinforced its study during the American Society of Clinical Oncology meeting in Chicago on Monday, saying that "Neoprobe has conducted the trials in accordance with the parameters discussed and reviewed with FDA." Company officials said they were confident that the application would meet FDA standards, according to a release.
The cancer diagnostics firm disputed the claims in MSMB’s petition, calling the allegations "flawed" and "unfounded".
Critics have been challenging Neoprobe’s trials since TheStreet.com columnist Adam Feuerstein raised an eyebrow at the study in May, shortly after the Dublin, Ohio-based company announced positive findings from Lymphoseek clinical trials.