Amylin Pharmaceutical (AMLN) investors got some long-awaited good news Friday afternoon, as the FDA finally granted approval to market Bydureon, an extended-release of Amylin's one-time blockbuster Byetta. Obviously this is a positive development for the company, but now the hard work begins. Amylin's market cap already assumed approval of this drug and now the company has to convince skeptical analysts and investors that it can steer itself to greatness (or buyout) as largely a one-product company.
Don't Tell Me About The Labor Pains, Just Show Me The Baby
Amylin has been working on getting approval of Bydureon since May of 2009, when the company first submitted a New Drug Application (NDA) to the FDA. The first FDA rejection came about a year later when the FDA wanted data on labeling and a risk mitigation strategy. The company resubmitted its response to these fairly routine questions only to get a second rejection in October of 2010 and a request from the FDA for a new trial to assess potential cardiac risk.
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Amylin Gets Its Yes; Now For The Hard Work
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