On September 26, 2011, Mela Sciences (NASDAQ:MELA) announced that it has received an “Approvable” letter from the FDA for its MelaFind hand held melanoma detector.
Before the market open on September 26, the company announced that it had received a letter from the US FDA in response to its Pre-Market Approval application on its flagship product MelaFind. The FDA has found MelaFind to be approvable as an aid to dermatologists for detecting early stage melanoma lesions. An approvable letter is usually functionally a preliminary approval, followed by a final approval from the FDA once the sponsor has addressed items raised in the approvable letter.
Approvable letters set out the final conditions that must be met to obtain final approval. In MELAs case it must, “… finalize the physician and patient labeling, package insert, user’s guide, training program and clinical protocol for a post-approval study…”. MelaFind is on target to launch in Germany by 2016
Recall that earlier this month, the company received CE Mark approval to market MelaFind in the European Union.
Shares of the company went up by 55.03% and trade closes at $4.93 after trading in the range of $4.53-$6.20. The stock has 52 week range of $1.75-$8.32. Currently, the market cap of the stock stands at $124.54 million with total outstanding shares of 25.26 million.
MELA Sciences, Inc., formerly Electro-Optical Sciences, Inc., is a medical device company focused on the design, development and commercialization of a non-invasive, point-of-care (in the doctor’s office) instrument to assist in the early diagnosis of melanoma.
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