MELA Sciences (MELA) Shares Soar on FDA Panel Vote for MelaFind, Final Decision Yet to Be Made
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MELA Sciences, Inc. (Nasdaq: MELA) shares are ripping this morning following a positive vote by a U.S. Food and Drug Administration panel, which noted that the benefit's of Mela's MelaFind melanoma diagnostic aid outweighed the risks. A positive panel vote does not necessarily mean that a drug will be approved, but the FDA will take into account, among other things, the panel's recommendation in making its final approval decision. A date for the final decision has not been made yet.
Leerink Swann & Co. made comments has made comments about the vote, and potential for MelaFind.
Leerink notes that the outcome has surprised many, and that the heavily shorted shares should soar today (which they are). The firm notes that the committee "swallowed some of its concerns and delivered a positive recommendation on MelaFind." Concerns of the panelists "included the limitations of available clinical data and analysis, and the effect of the tool on patient health when used by a less expert physician."
Many panel members "lamented" that the study did not put MelaFind against a physician's eyes in order to discern relative sensitivity, leaving judgement of the clinician's performance to historical literature. They were also concerned that the device may be used as a de facto> go-to for less experienced doctors, as opposed to its intended use as a detection aid.
The firm is pegging Q111 for an FDA decision on MelaFind.
Leerink has an Outperform on the stock and, pending the company call this morining, increased their central value on the shares from $4 to $11.
Shares of Mela are up over 100% premarket today.
Leerink Swann & Co. made comments has made comments about the vote, and potential for MelaFind.
Leerink notes that the outcome has surprised many, and that the heavily shorted shares should soar today (which they are). The firm notes that the committee "swallowed some of its concerns and delivered a positive recommendation on MelaFind." Concerns of the panelists "included the limitations of available clinical data and analysis, and the effect of the tool on patient health when used by a less expert physician."
Many panel members "lamented" that the study did not put MelaFind against a physician's eyes in order to discern relative sensitivity, leaving judgement of the clinician's performance to historical literature. They were also concerned that the device may be used as a de facto> go-to for less experienced doctors, as opposed to its intended use as a detection aid.
The firm is pegging Q111 for an FDA decision on MelaFind.
Leerink has an Outperform on the stock and, pending the company call this morining, increased their central value on the shares from $4 to $11.
Shares of Mela are up over 100% premarket today.
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