Gamma camera probe developer Neoprobe said that a citizen petition has been filed with the U.S. Food and Drug Administration (FDA) by a holder of a short interest in the company's stock.
The vendor said the premise of the petition is flawed and that it continues to believe in the clinical and scientific validity of its trials, including the use of vital blue dye as the appropriate comparator for registration purposes based on discussions with the FDA. Neoprobe is moving forward with its plans to file a new drug application (NDA) in the third quarter.
In addition, the firm said it is assessing options with its public relations, regulatory, and legal advisors to address the unfounded information presented in the petition.
