Lipocine Inc (LPCN)

[danobrew]

The mistake was definitely not trivial. I had correspondence with the CFO shortly after the CRL and it basically came down to LPCN not knowing for sure that the dosing algorithm that they adopted from Eli Lilly would be acceptable to the FDA. Since LPCN did not know the threshold of dosing discordance that would be acceptable - they made assumptions about how Eli Lilly's algorithm apparently passed muster. An issue that more open communication with the FDA should have nipped in the bud. This speaks to black box relationship between drug companies and the FDA. Hoping they have all the answers queued up and beyond reproach when they finally meet with the FDA.