The FDA decision on Pfenex Inc.’s (PFNX) lead product candidate PF708, a therapeutic equivalent candidate to Forteo, for the treatment of osteoporosis, is expected by October 7, 2019. The New Drug Application for PF708 was submitted to the FDA under the 505(b)(2) regulatory pathway, which allows a company to rely, at least in part, on the FDA's findings of safety and/or effectiveness for a previously approved drug (the "reference drug"), and provides for a shorter and less costly drug development program.In the case of PF708, Forteo is the Reference Listed Drug. It was approved by the FDA in 2002.Forteo, which is marketed by Eli Lilly and Co. (LLY) for the treatment of osteoporosis in certain patients with a high risk of fracture, achieved $1.6 billion in global product sales in 2018.Pfenex’s development and licensing partner for PF708 is privately owned Alvogen, which is responsible to manufacture and commercialize PF708 in the United States.PF708 is also under review in the European Union. PFNX closed Friday’s (Sep.27, 2019) trading at $8.51, down 3.19%.