This Day On The Street
Continue to site right-arrow
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
Stocks Under $10 with 50-100% upside potential - 14 days FREE!

Mela Device Approval a Win With Conditions

Stocks in this article: MELA CYBX

IRVINGTON, NY ( TheStreet) --Congratulations Mela Sciences (MELA). The campaign of legal and political pressure paid off. The U.S. Food and Drug Administration reversed course and granted conditional approval for the company's MelaFind skin cancer detection device.

Mela shares were up $1.92, or 60%, to $5.07 in Monday trading.

Critics like myself who doubted this day would ever come, especially without a new pre-approval study, were wrong.

Well, sort of wrong, since Mela Sciences can't begin selling MelaFind until it reaches agreement with FDA to resolve a list of open issues in the "approvable" letter. These include reaching final agreement on the device's final labeling, a user guide, the details of a training program for doctors and the design of a post-approval clinical trial.

On a Monday conference call, Mela CEO Joe Gulfo sounded uncertain about when FDA would actually approve MelaFind and was careful to downplay launch expectations if and when the company does begin selling the device.

Gulfo said final negotiations with FDA on the outstanding MelaFind issues were substantially complete but then he acknowledged that these discussions with the agency were still going "back and forth" and therefore not complete. He declined to offer a guess on when FDA would issue a final approval for MelaFid but he did say the company hopes to start selling the device in the first quarter of 2012.

Before Mela launches MelaFind, the company is also going to conduct additional "beta tests" with doctors to make technical and usability improvements to the device Gulfo said.

When MelaFind is finally launched in the U.S., sales will be restricted to dermatologists who must first complete a training course on the device's use. Mela initially hoped to market MelaFind more broadly to general practitioners.

MelaFind's label describing how the device should be used is four paragraphs long and includes various restrictions and warnings on the types of lesions to be tested and how to interpret results. Gulfo, on Monday's call, acknowledged the MelaFind label is longer and more complicated than the company had envisioned when it submitted the device for FDA approval.

1 of 2

Select the service that is right for you!

Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!


DOW 17,804.80 +26.65 0.15%
S&P 500 2,070.65 +9.42 0.46%
NASDAQ 4,765.38 +16.9840 0.36%

Brokerage Partners

Rates from

  • Mortgage
  • Credit Cards
  • Auto

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs