More than two years, two panel reviews and one citizen’s petition after Mela Sciences (NSDQ:MELA) signed on for a 6-month FDA review of its MelaFind melanoma detection system, the company landed an "approvable" letter from the watchdog agency and is finally on track to winning regulatory clearance for the U.S. market.
Though Mela Sciences still has a few questions to address before getting the watchdog agency’s green light, CEO Dr. Joseph Gulfo is confident that things will go more smoothly this time than the first time around when "Something just went totally off the tracks," he told MassDevice.
Mela Sciences’ plight has made it a poster child for charges of unpredictability at the FDA, culminating with a Progressive Policy Institute report, "Is the FDA Strangling Innovation?" The report concluded that the FDA was "clearly blocking innovation" in not granting a PMA for the company’s MelaFind skin-cancer detection device.
Click here to listen to the MassDevice podcast interview with Mela Sciences CEO Dr. Joseph Gulfo
"What I attributed it to was the fact that there were a lot of changes in the device world," Gulfo told us. "There were changes to the 510(k), evaluation of the IOM report, evaluation as to whether there would be a new class, re-writing guidances. I just felt that we got caught up, we were collateral damage in all those efforts going on."
In July 2009, Irvington, N.Y.-based Mela Sciences, then known as Electro-Optical Sciences, submitted a pre-market approval application for the MelaFind. The company had already signed a definitive agreement with the FDA in 2004 detailing the precise path to clearance and had launched the largest melanoma trial to date to support its application.
The system proved highly effective in the trials. Mela anticipated FDA panel review in Q1 of 2010, but got an "unapprovable" letter instead. The negative vote "poisoned" public and medical opinion against he company, Gulfo told us, and led to several lawsuits from shareholders who saw a significant loss when shares sank abruptly from $6.37 on Nov. 15, 2010, to $2.53 just two days later, a 60 percent slide.
"It’s very important to understand that that non-approvable letter was illegal," Gulfo said. "It was illegal because MelaFind is a breakthrough PMA product and a first-of-a-kind product and the statute, the regulations, say that a product of that type has to undergo an advisory committee meeting prior to a decision letter. MelaFind was denied that right."
In a one-on-one interview with MassDevice, Gulfo told us about the company’s long road, the moral of its story and its goals for commercial launch in the near future.
Click here to listen to the MassDevice podcast interview with Mela Sciences CEO Joseph Gulfo.