The FDA has been playing a rough game of "Whack-A-Mole" lately, smacking down would-be drugs in the fields of obesity, diabetes and psychiatry, and hitting the stocks of companies like VIVUS (Nasdaq:VVUS), Arena Pharmaceuticals (Nasdaq:ARNA) and Alexza (Nasdaq:ALXA). With a very aggressive pre-panel meeting review, investors are now extremely nervous that the agency is about to do the same to MELA Sciences (Nasdaq:MELA) and MelaFind, the company's would-be testing device for melanoma (a very serious type of skin cancer).
A Consummate Binary Event
For investors who are not familiar with the term "binary event", the FDA's ultimate decision on MelaFind is a very good working definition. While large medical device companies like Stryker (NYSE:SYK) or Medtronic (NYSE:MDT) need FDA cooperation to thrive, it is more of a matter of survival for MELA Sciences.
For investors who are not familiar with the term "binary event", the FDA's ultimate decision on MelaFind is a very good working definition. While large medical device companies like Stryker (NYSE:SYK) or Medtronic (NYSE:MDT) need FDA cooperation to thrive, it is more of a matter of survival for MELA Sciences.
If the agency grants approval, the company will be able to enter a large field with no other comparable competitive device option. If the agency refuses to allow MELA to market this device, the company has nothing else in its bag and will effectively be a zombie company. In other words, the stock will go up a lot if the FDA approves MelaFind, or down a lot if MelaFind is rejected. Not surprisingly, then, there has been a huge amount of stock shorting interest and option activity going into Thursday's panel meeting.
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