With the FDA's decision date on the approval of Xiaflex for the treatment of Peyronie's disease looming (September 6), considerable attention has come to Auxilium Pharmaceuticals (AUXL) in recent weeks. While the FDA's decision is absolutely a significant event for the company, investors shouldn't overlook the company's challenges in its existing specialty pharmaceuticals business, as well as the efforts that will have to go into making Xiaflex a winner in Peyronie's assuming approval.
The FDA - Will They Or Won't They?
Time and time again, the FDA has demonstrated that predicting the agency's behavior is challenging at best. In the case of Xiaflex for Peyronie's disease, I'm optimistic. The results from two Phase III studies showed efficacy,...
Only subscribers can access this article, which is part of the PRO research library covering 3,603 different stocks.
Growing numbers of fund managers and other investment professionals subscribe to Seeking Alpha PRO for equity research that is unavailable elsewhere, so they can: