Gulfo
Mela Sciences (NSDQ:MELA) CEO Dr. Joseph Gulfo raised $130 million, lead what he calls the “largest prospective clinical study ever conducted in melanoma detection” and developed a product he believes can help make a dent in the thousands of deaths that happen every year from skin cancer, but he can’t get his calls answered by the FDA.
More than two years into a “six month review” for FDA approval on a hand-held biopsy device for skin cancer , MELA is still languishing in a regulatory purgatory, despite getting a positive panel review vote back in November 2010.
The company filed a 35-page “citizen’s petition” to Food & Drug Administration commissioner Margaret Hamburg in May, asking her to enforce a binding protocol agreement and investigate the company’s pre market application for the Mela Find device.
Read more of MassDevice’s coverage of Mela Sciences’ troubles with the FDA
All that and Gulfo told MassDevice that the company still hasn’t heard boo from the watchdog agency.
“We’ve received no response,” he told us. “What we were looking for with that petition was transparency. It’s really the buzzword of administration and this FDA and all we want is transparency. In that petition we laid out for the commissioner the 6 or 7 ways that the protocol agreement was violated and another 6 to 7 ways in which the FDA regulation was violated.”
Gulfo’s contention is that the FDA hasn’t played it straight with MELA, which he said entered into a binding protocol agreement with the agency in 2004 before conducting a clinical trial and has made amendments to its application at the behest of the agency.
“When I say this is egregious it’s because we did everything right,” he told us. “We cut no corners. We picked most rigorous ways to go and we were successful. And to be in the 25th month of a six month review with one American an hour dying because doctors miss this dreadful disease when it’s curable is really unconscionable.”
The MelaFind instrument uses a computer-controlled multi-spectral dermoscope, employing light to image the skin through a thin layer of liquid (alcohol or oil), making lesion structures under the skin surface visible to dermatologists. The device records the images, which are sent to a computer that uses an algorithm to compare it with pictures of thousands of malignant and benign lesions to determine the likelihood of skin cancer.
Mela claims the procedure can help dermatologists easier identify skin lesions, which should be biopsied for risk of cancer.
A clinical trial of 1,300 patients in 2009 showed that the MelaFind’s ability to detect cancerous lesions was 2.5 times greater than a dermatologist’s, according to media reports.
The FDA’s General & 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 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.
Gulfo said that the panel vote would have been much more in MELA’s favor had the device’s indication been limited to dermatologists rather then all physicians.
“You invest that time to lock onto the best study design and now you have two more years after that,” he told us. “That’s not what investors signed on for. I raised $130 million on that very rare binding agreement. This is not appropriate.”
Still, he said the company is not giving up. It plans to file for CE Mark to sell the device in Europe and he still has faith that the FDA will see through on the panel’s decision and clear the device for market. He also dismisses the notion that there’s anything personal in the company’s public case against the agency. He believes that the company is simply a casualty of the current political climate.
“We’re collateral damage in the efforts to re-design the 510K program,” he told us. “I’m just being a megaphone for transparency.”
Repeated calls to the FDA seeking comment were not returned as of publication.
