After normal trading hours had closed MELA announced the following disappointing news:
MELA Sciences Announces FDA Needs More Time to Arrange Panel Meeting to Review MelaFind(R) PMA Application
MELA Sciences, Inc. (NASDAQ: MELA) announced today that the U.S. Food and Drug Administration (FDA) has informed the company that it is moving the General and Plastic Surgery Devices Panel for MelaFind(R), which was originally scheduled for August 26, 2010, to November 2010.
“The FDA informed us today that more time is required to arrange the meeting,” said Joseph V. Gulfo, MD, President & CEO. “We are ready to go now, and we will maintain our state of preparedness. This is untimely, however, it is not totally surprising given that the meeting was originally scheduled for the last week of the summer. We look forward to the revised Federal Register announcement of the specific date in November.”
Obviously this will negatively impact the share price of MELA. Currently MELA is down to $5.75 in after hours trading. The news is not catastrophic, but many traders (myself included) will sell, as there are many other biotech plays to be made before the November panel. I sold almost all of my shares in after hours at various prices ranging from $6.10 – $5.80. However, to some who do not want to sell for a loss, MELA should run back up before its November panel.