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Mela Sciences (MELA) has lost almost half its market cap this morning, after an FDA staff report...

Mela Sciences (MELA) has lost almost half its market cap this morning, after an FDA staff report says Mela's skin cancer device "may do more harm than good." The device faces the FDA's advisory panel on Thursday. Shares -47% to $3.37.
Comments (4)
  • Tony Petroski
    , contributor
    Comments (6373) | Send Message
     
    "...has lost almost half its market cap this morning, after an FDA staff report says Mela's skin cancer device "may do more harm than good.'"

     

    But another staff report said that Mela's device was pretty good so...

     

    Disclosure: Don't own Mela.

     

    Wary of the FDA.
    16 Nov 2010, 09:43 AM Reply Like
  • gstgeorge
    , contributor
    Comments (10) | Send Message
     
    ...and I do own some Mela, though only a little.

     

    Two things are clear. First from the options trading previous to the news today, it is clear that a lot of inside info on these decisions leaks out. Therefore if you trade these things without inside info you are a fool. (Like me.)

     

    The other, after reading the FDA's report is even sadder. If you want to do something really innovative medically you'd be best not starting in the U.S., where the built in inertia and stupidity of an organization like the FDA will bankrupt you. This idea could have really helped some people.
    16 Nov 2010, 06:32 PM Reply Like
  • jrusso9722
    , contributor
    Comments (94) | Send Message
     
    Tony and gstgeorge,

     

    I'll agree with you both. MelaFind won't be used in a vacuum. The doctor has final say. It's an aid for doctor-patient consultation, and decision making. Melanoma, as you know, is so dangerous, FDA should allow doctors it's usage. Any patient would be glad to be scanned by MelaFind. If FDA members, or loved ones were suspicious of a mole, they would want a MelaFind scan to aid the doctor. People can be smart, but stupid also. "Do more harm than good" is an OUTRAGEOUS statement, and hints at a hidden agenda.
    16 Nov 2010, 07:20 PM Reply Like
  • roblites
    , contributor
    Comments (148) | Send Message
     
    I've been in a lab that examines suspected skin cancer samples for other doctors . There is a table with 4 Doctors looking thru microscope extensions which radiate from the lens and sample.
    Each has there own personal interpretations to help reach a consensus. Melafind was never conceived to be anything more than a just more information to help the Doctors come to his own decision. This is especially important if Melafind discovers something the Doctor didn't perhaps, making him to investigate further and maybe deciding to send the sample to such a committee as I observed. You can read the report simply by going to FDA site and plugging in the company name in the search box. What I found was a report where they clearly interpret that the company research didn't follow their terse instructions. It's like,"you didn't structure the research the way we instructed"..Right,even if it didn't make any sense. There is an open hearing ,I think tomorrow, and the company will clearly have their day,but the FDA noted that contributors will be limited to time available. Control,incase the discussion becomes insulting to their logic?......I'm long calls,holding and annoyed.
    17 Nov 2010, 10:26 AM Reply Like
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