I believe the current uncertainty comes down to 2 things: manufacturing and sales teams. Until there is clarity on the direction the company takes on both of these issues, either through partnership or raising capital, many institutional investors will feel there is too much uncertainty for investment. At this time, large investors are waiting to see if Odidi and Della Penna can execute the buildup for rollout of Rexista.
Manufacturing: IPCI can manufacture in-house OR sign a contract manufacturing agreement OR partner. Manufacturing in-house will cost on the order of $5M-15M, depending on building purchase/rental and the scale of manufacturing. Even more important, if they do in-house manufacturing, they need to do the build-out and then get FDA approval of the manufacture sight as CGMP (current good manufacturing practice), which will likely take 12-18 months if they start now! In my mind, it's too late to do the manufacturing on their own, so they either have to do contract manufacturing or get a partner. In that they haven't announced a contract manufacturer at this stage of the game, a partner with CGMP-approved manufacturing capability is the most likely scenario.
Marketing: again, either in-house OR sign a contract marketing/sales agreement OR they need a partner. I don't see any signs of hiring a sales team which, once fully staffed, will likely cost $1.5-3M/quarter. Too much of a burden for IPCI at this stage. Contract sales is a possibility, but again, I think a partnership is the most likely scenario.
If we are waiting on a partnership, why isn't it signed yet? Clearly, they can't agree on terms (upfront payment, royalty, milestones). My best guess is that a potential partner is waiting for more certainty before meeting IPCI's negotiation demands. Just finishing the filing (due any day now) only gives a little reassurance to a partner, so the partner may be looking for acceptance of the filing by the FDA (the 74-day letter). But, one thing is clear: Manufacturing/sales teams must be put in place within the next few months, or the rollout of Rexista (hopefully in February) will be delayed.
One thing that may be holding up a partnership: TEVA (a potential partner) has just completed a $40B acquisition of the generic business of Actavis. Until the merger of this business unit is complete, TEVA management might have a moratorium on any new partnerships.
My costs and timelines for manufacturing/sales teams are just estimates. I welcome any corrections.
