A failure of Lipocine Inc.'s Tlando (testosterone undecanoate) to meet any of its three pre-specified maximal serum testosterone concentrations (Cmax) secondary endpoints highlights a series of issues the testosterone replacement therapy will have to overcome in front of a US FDA panel in its quest for approval.
Lipocine Testosterone Therapy Faces Safety, Stopping Criteria Concerns At US FDA Advisory Cmte
Tlando's product would offer convenient oral route of administration, but may carry some secondary (endpoint) problems.