Mr. Kolbert introduced call by saying that Omeros is one of his favorite undervalued opportunities. He noted that PII 103HP menisectomy data (a relatively larger PII trial that wasn't powered to show statistical significance, yet did so) is very suggestive that ACL PIII data should be positive.
Comment by Dr. Demopulos that PIII was over-enrolled, and reitereated that they anticipate data from the PIII should still be forthcoming in Q1.
Omeros has already begun preparing 103HP NDA. Assuming positive data, NDA should be able to be filed in Q2 of 2011. (Would likely lead to 2H 2012 launch.) Dr. Demopulos commented that Omeros' current plan is to use a specialty sales force (one that already exists... not one that they plan to establish) to sell to ortho docs, although cannot rule out partnership.
Some additional discussion of GPCR program and new antifibrinolytic assets. Re: GPCR program, Dr. Demopulos conveyed that while Omeros may retain rights to some targets, the go-forward plan is primarily to monetize this program sooner rather than later via outlicensing activities. Re: antifibrinolytic program, emphasis was that this program entails a plasmin-selective inhibitor to replace Trasylol®, which was withdrawn from the market in 2008 due to off-target (non-plasmin-selective) issues. (I note that Trasylol® hit peak sales of $338M before being pulled from the market... with projections that it could have hit $500M to $1B in sales.)
In summary, there was no new data revealed on this call, but it provided a nice summary of Omeros' R&D pipeline. Mr. Kolbert did comment in closing that while recent PPS for Omeros has seen some pressure, all the fundamental data / information available about the Company are positive.