Deconstructing the Lipocine Inc (LPCN) Complete Response Letter

There’s only one real outcome, therefore, and that’s a phase III do-over. We know that Lipocine intends to talk to the FDA regarding the next step across the next few weeks, and we should get some official word on what the company needs to do at that point, but given the situation, there’s no other real option available. This is a problem for Lipocine, as it’s not particularly cash rich right now.

The phase III submitted as the NDA data started in Feb 2014 and completed around twelve months later. During this time, Lipocine spent around $12.5 million (based on Dec 14 – Dec 15 numbers) on research and development. It’s reasonable to assume that the majority of these costs went towards the completing of the LPCN 1021 phase III. Let’s say the trial cost $10 million, which is on the low side. At last count (March 31) Lipocine had $14.1 million cash on hand – barely enough to cover the costs of a redo over the phase III; a redo that the FDA will in all likelihood require to support the suggested titration scheme in the NDA.

There’s a chance, of course, that Lipocine Inc (NASDAQ:LPCN) will be able to alter the suggested scheme in the NDA to fall in line with the already established data. This will be less costly, but still drawn out. The takeaway here is that this does look like a delay based CRL rather than a complete write off, but whatever happens it’s going to be a drawn out solution, and at worst it could clean out the company’s current entire cash holding.

Note: This article is written by Mark Collins and originally published at Market Exclusive.