MELA Gets New Signs of Life After FDA Panel (MELA)

November 19, 2010 · Filed Under Cancer, fda 

MELA Sciences Inc. (NASDAQ: MELA) turns out to not be as dead of an issue as its stock performance was indicating over the last week.  Unfortunately, there are caveats here.

The company’s experimental skin cancer detection device called MELAFind won FDA panel backing.  The problem is that the vote was a mere 8 FOR versus 7 AGAINST. Some expressed concerns that the device actually works better than a traditional doctor screen.  Others believe that the device offers a new hope.

Either way, the panel vote is a win for the company.  The device still has to face a formal FDA approval.  The computerized system aims to help dermatologists decide whether or not skin lesions need further biopsy to find melanoma.

The FDA had brought up concerns and MELA shares hit skid row.  There are still some very large risks here.  It is possible that the FDA could vote against MELA and there could be a request for new tests.  What matters today is that the “FOR” vote won.  Whether or not formal approval comes is something that will be discovered soon.

Shares are up 110% at $5.30 in very active pre-market trading.  MELA’s market cap had sunk to only about $64 million before today’s major pop.  Shares closed at $2.53 yesterday and the 52-week trading range is $2.51 to $12.24.

UPDATE 9:55 AM EST: MELA shares are up 115% at $5.45  on more than 6 million shares.

JON C. OGG

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