
After nearly two years of waiting for an answer from the FDA on its hand-held biopsy device for skin cancer, Mela Sciences (NSDQ:MELA) is taking to the streets.
The company filed a 35-page “citizen petition” with the office of FDA commish Dr. Margaret Hamburg, demanding that she directly oversee the company’s pre-market approval application for its MelaFind device and investigate the circumstances under which the company’s application has languished for more than 23 months.
Read more of MassDevice’s coverage of Mela Sciences’ troubles with the FDA
Mela Sciences went before an FDA panel in November 2010 but has heard nothing from the agency, according to company CEO Joseph Gulfo.
“The silence has been deafening to us,” Gulfo said in a conference call this morning. “What we’ve experienced is unlike anything I’ve seen in 23 years. I’ve never seen the FDA not meeting with a company after a panel meeting.”
The FDA’s General and Plastic Surgery Devices advisory panel recommended approval of the device on a narrow 8 to 7 vote Nov. 18, 2010. The review panel’s vote is non-binding, but the FDA often takes its cues from advisory panels in making final rulings on PMA applications. The vote came two days after the release of a scathing internal FDA review of the Irvington, N.Y.-based company’s MelaFind device. The FDA said the device as a biopsy replacement may cause "more harm than good," was not studied adequately and urged the company to run a new clinical trial.
Company officials said they have about $26 million in cash reserves, which should hold them for some time at its current burn rate of $1.3 million to $1.4 million per month.
Gulfo described the petition as part of Mela Sciences’ regulatory strategy.
“We welcome transparency, because transparency favors this with the results, the science and the research,” he said. “We need to shine a light on this review because we believe this process has simply gone awry.”
Mela Sciences first filed its PMA with the FDA in June 2009.