After having been turned down by the FDA in 2013, Agile Therapeutics Inc.’s (AGRX) investigational low-dose combined hormonal contraceptive patch Twirla is back at the FDA altar – with a decision anticipated on December 26, 2017.While rejecting Twirla in 2013, the FDA had asked the Company to conduct a new clinical trial and provide additional information on the manufacturing process for the hormonal contraceptive patch.In order to address the issues raised by FDA, the Company conducted a phase III study, known as SECURE, which evaluated Twirla in 2,032 healthy women, aged 18 years and over, at 102 investigational sites across the United States. The study was successful, and the results were also included in the resubmitted NDA. If approved, Twirla will be Agile’s first product to be commercialized. Corium International Inc. (CORI) is the exclusive manufacturer and supplier of Twirla.AGRX closed Tuesday’s (Nov.28) trading at $5.14, up 0.39%.