Listened to the webcast and several things stood out:
1) Expect better results from ESTABLISH-2 due to IV bioavailability being higher than oral. Patients at sites in Europe tend to have larger lesions (due to delay in treatment by Europeans) and from previous data analysis, Tedizolid (TZD) shows better results in these patients than Zyvox. Jeff Stein said this trial is pretty much "de-risked" from an investment standpoint.
2) Jeff Stein CEO said, "we are in partnership discussions." He recently posted on twitter that management has been undergoing partnership training seminars via a professor at Harvard. Eluded that big pharma has high interest and that there is no hurry to partner until after ESTABLISH-2 data is released. They can command better terms with great results that are expected from this trial. To note, Trius has a ATM (at the market) financing deal with that will sell up to $25 million dollars worth of stock at Trius' discretion. This also gives flexibility for management not to feel rushed to partner.
3) Trial to be completed by December with top-line data by March/April. NDA filing in Q3 (July-Sept) with a 6-8 month review under GAIN Act placing approval at the beginning of 2014.
There are lots of catalysts to drive the share price coming up. Lots of analyst upgrades recently with $10-15 price targets. One analyst said if TZD gets approved and sells at same price as generic Zyvox downside is $4.50/share showing limited downside. However, based on recent data, TZD is very differentiated from Zyvox--- better side effect profile, less drug-drug interactions, once daily dosing for 6 days vs 10-14 with Zyvox. Jeff Stein said from a pharmaco-economic standpoint, TZD may have additional cost savings vs. Zyvox or a generic Zyvox by getting patients treated and out of the hospital sooner. Each day in the hospital can be thousands of dollars. TZD is bacteriacidal vs bacteriostatic like Zyvox. This leads to less resistance and faster resolution and shorter course for treatment. MRSA is growing resistant to vancomycin and even Zyvox to a lesser extent. TZD has been able to treat resistant Zyvox MRSA strands. On a final note, Trius is looking to start more trials for bacteremia and pneumonia. We already know TZD has in-vitro activity for MRSA and reaches these sites of action, it's now just a formality of doing the studies and getting additional indications approved. Gyrase program will begin the beginning of next year as well.
There are lots of things to be excited about in 2013.