Investigation Overview
An investigation on behalf of current investors in MELA Sciences, Inc. (NASDAQ:MELA) over possible breaches of fiduciary duties by certain officers and directors of MELA Sciences in connection with the recent FDA news relating MELAs skin cancer diagnosis product MelaFind was announced.
On Nov. 16 2010 MELA Sciences, Inc. (NASDAQ: MELA) announced that the U.S. Food and Drug Administration's (FDA) General and Plastic Surgery Devices Panel will review the company's Pre-Market Approval application for MelaFind(R) on Thursday, November 18. The same day a media report stated that U.S. health regulators said Mela Sciences Inc's experimental device to help diagnose deadly skin cancer could cause harm because of the potential for misdiagnosis. FDA staff said in documents released on Tuesday ahead of an FDA advisory panel meeting on Thursday that 'The FDA review team has significant concerns this device has not been studied adequately for its current indications for use and therefore puts the health of the public at risk.
Shares of MELA Sciences, Inc. fell from over $8 per share in October 2010 to $2.92 on November 16.
The investigation by a law firm concerns on whether certain directors and officers of MELA Sciences, Inc. (NASDAQ:MELA) violated their fiduciary duties in connection with the concerns recently raised by the U.S. Food and Drug Administration's (FDA) General and Plastic Surgery Devices Panel. The investigation, among other things, focuses on whether anyone has taken advantage of the current situation and whether certain directors and officer breached their fiduciary duties in regards to the latest news.
MELA Sciences Net Loss went from $10.59million in 2006 to a $18.45million Net Loss in 2009. For the first three quarters in 2010 MELA Sciences, Inc. reported a combined 9month Net Loss of $14.6million. As of Sept. 30, MELA Sciences had about $35.8 million in cash and cash equivalents and said it was enough to fund operations for at least 12 months. But MELA Sciences also said in a regulatory filing that it might require additional funds to 'achieve significant commercialization of MelaFind.'