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FDA Rejects Lipocine's TLANDO Yet Again

The FDA has turned down Lipocine Inc.'s (LPCN) TLANDO, an oral testosterone product candidate for testosterone replacement therapy in adult males for hypogonadism, yet again.

The regulatory agency has cited the failure of the efficacy trial to meet the three secondary endpoints for maximal testosterone concentrations ("Cmax") as the reason for denying approval to TLANDO.

Mahesh Patel, Chairman, President and Chief Executive Officer of Lipocine, said, " We are disappointed by the FDA's decision and intend to request a meeting with the FDA as soon as possible to discuss a potential path forward for the approval of TLANDO."

The FDA had turned down TLANDO in June 2016, citing deficiencies related to the dosing algorithm for the proposed label, and in May 2018 too, saying that the product could not be approved in its current form.

This is for the third time that TLANDO has failed to secure the FDA nod.

LPCN closed Friday's trading at $2.73, down 2.50%. In pre-market trading on Monday, the stock is down 34.07% to $1.80.

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