Agile Therapeutics Inc (AGRX)

[mellow fellow]

The Company met with DBRUP on December 11, 2018 in order to discuss the specific design and success criteria of the comparative wear study. In general, the Company expects to conduct a crossover wear study in healthy women with a Body Mass Index (BMI) less than 35 kg/m2 who will be randomized to either Twirla or Xulane for the first week and then switched to the patch not initially worn for the second week.

“After we receive the final meeting minutes from the FDA in January, we will be able to provide additional details on the final study design. Our current plan is to complete the study in the first quarter of 2019, and to resubmit our Twirla new drug application in the first half of 2019, which, if we are successful, provides us the opportunity to receive approval by the end of 2019,” said Al Altomari, Chairman and Chief Executive Officer of Agile Therapeutics, Inc.