Labeling and Script Use May Cause Problems For Optimer Pharmaceuticals, Inc.'s New Drug
Optimer Pharmaceuticals (OPTR) is quickly approaching its May 30 PDUFA as as heavy favourite to win a positive vote from the FDA to market its product, yet it seems that many investors are discounting the potential for a surprise negative outcome.
The company is trying to obtain approval for its flagship product, fidaxomicin which could make it the first Clostridium defficile infection (CDI) treatment in more than 25 years. Currently, the infection only has two pharmacological options as treatments: metronidazole and oral vancomycin, both of which lack the ability to reduce recurrences, while improving global cure rates.