Yesterday, Amgen Inc (AMGN) announced that the US Food and Drug Administration (FDA) delayed the approval of its osteoporosis drug denosumab, with a proposed trade name of Prolia.  In response to the Biologic License Applications (BLA) filed by Amgen in Feb 2009 for Prolia, the Complete Response Letter (CRL) issued by the FDA requested several items, including further information on the design of Amgen's previously submitted post-marketing surveillance program. The FDA has asked the company to develop a strategy to evaluate the risks of Prolia. However, the agency did not ask for further clinical trials, which would have resulted in a longer delay.  Management believes that it can satisfy the queries of the FDA. The company intends to market Prolia for the treatment and prevention of postmenopausal osteoporosis (PMO) and bone loss in patients undergoing hormone ablation for either prostate or breast cancer.  Based on ...