Complete Response Letter from FDA to Lipocine Inc., for Tlando for testosterone replacement therapy.

Lipocine Inc. announced that it has received a Complete Response Letter from the FDA regarding its New Drug Application ("NDA") for Tlando, the Company's oral testosterone product candidate for testosterone replacement therapy ("TRT") in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism. A CRL is a communication from the FDA that informs companies that an application cannot be approved in its present form. The CRL identified one deficiency stating the efficacy trial did not meet the three secondary endpoints for maximal testosterone concentrations . The CRL does not identify any specific issues relating to the chemistry, manufacturing and controls of Tlando.