Replies to post #605 on Lipocine Inc (LPCN)

[grizzly2314]

Well, that would certainly be better than another CRL. I don't see Clarus' exclusivity being an issue. I believe Tlando being fixed dose while Jatenzo requires titration will be the difference. That's just my opinion. Jatenzo's exclusivity is based on the following taking from the Exclusivity Summary (link below):

https://www.fda.gov/media/138223/download

The determination is consistent with FDA’s decision to recognize exclusivity for other testosterone replacement therapies that have received exclusivity in the past based on the same general study design (a phase 3 study with a primary efficacy endpoint of the proportion of treated subjects with a T Cavg within the normal range after dose titration was complete).