WASHINGTON, D.C. (
: Not so
An FDA advisory panel voted Thursday night 8-7 in favor of recommending the approval of MELA's MELAFind skin cancer detection device. A lone panel member abstained from the final vote.
The positive vote in MELAFind's favor came despite strongly worded statements from FDA reviewers at the meeting that the MELAFind clinical data, as submitted, did not support the device's approval.
Regardless, MELA is still very much alive, so I need to eat some crow. I predicted a negative vote at Thursday's panel based on the overwhelmingly negative critique of MELAFind released by FDA in advance of the panel.
Congratulations to MELA and its chief executive Joe Gulfo. The company dealt with withering questions and criticisms from the panel and FDA and ultimately got the positive vote it sought.
MELA shares were halted for trading all day Thursday at $2.53. The stock, heavily shorted, will almost certainly head higher once trading opens again. How much so depends on how confident investors feel about the eventual approval of MELAFind.
Advisory panels are just that, advisory, which means the final approval decision resides with FDA. I spent 10 hours
and what I heard from the FDA didn't seen overly reassuring for the prospects of MELAFind's near-term approval.
"The FDA review team recommends that this device needs a new prospective study," is how the FDA summed up its presentation to the panel members before the voting began.
Whether the close 8-7 vote tally on the question of MELAFind's risk-benefit and the overall comments from the panel members persuade FDA to soften its negative opinion and approve MELAFind remains to be seen.
In many ways, the MELAFind panel reminds me of another contentious medical device panel. In 2004, FDA was harshly critical of
effort seeking the expanded approval for a nerve stimulation device as a treatment for patients with severe depression. The FDA's review of the Cyberonics' device was very negative yet an advisory panel still voted to recommend approval. The FDA decided to ignore the panel's vote and rejected the device.
All day Thursday, panel members assessing MELAFind were split over the adequacy of the device's ability to accurately detect melanoma. Skeptics on the panel argued that the device was unnecessary or potentially harmful because of the risk of misdiagnosis i.e. too many false negative results, especially if used by doctors not skilled enough to interpret results. Concerns were also raised that the device's low specificity i.e. rate of false positives would lead to an increase in the number of unnecessary biopsies.
On the other side, panel members supportive of MELAFind argued that the device could be a valuable tool that would help doctors make better, more accurate diagnoses of melanoma. MELA argued that the clinical data compiled showed MELAFind to be more accurate than current methods used to screen for melanoma.
"We believe this is a very important product for patients and that our efforts in the disease are important... I felt that the panel focused on possible negatives but I focus on possible positives of MelaFind," said MELA's Gulfo during his concluding remarks.
Perhaps indicative of the volatile and confusing nature of the entire day's proceedings, the FDA's electronic voting system broke down just as voting was to begin. This forced the panel to vote using paper ballots.
--Written by Adam Feuerstein in Boston.
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Adam Feuerstein writes regularly for TheStreet.com. In keeping with TSC's editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet.com. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback;
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