Lipocine (NASDAQ:LPCN) has received a second Complete Response Letter (CRL) from the FDA regarding its refiled marketing application for testosterone replacement therapy candidate Tlando.
This time the agency cited one issue (instead of four the first time): the efficacy trial failed to meet the three secondary endpoints for maximal testosterone concentrations (Cmax).
The company intends to request a meeting with the agency to clarify a path forward.
The company received the first CRL in May 2018.
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