Based on the 112 trial, I would give this stock 90% chance of approval for skin and soft tissue infections. The unknown is the current phase 3 evaluating lung infections. Based on it's non-inferiority trial with Zyovx by pfizer where it matched, or did better in all primary and secondary end points with improvements adverse effects and tolerability. However, the FDA is in the process of debating how they want to evaluate anti-infectives for approval purposes and some criteria can change, but Trius is covering all their bases on this one.
I currently hold 4,000 shares myself and I don't feel it's speculation based on my assessment. This is my personal opinion and I'm long TSRX. I'm also a pharmacist.
I pretty echo what you've just said. I feel very confident TSRX is on the verge of becoming one of the Specialty Pharma/Biotech companies with a state-of-the-art technology in discovering best and/or first in class antibiotics.
Given that Zyvox is a potent and very effective drug (sales numbers reflect this), it is not a small feat to show that tedizolid is non-inferior to Zyvox. Add GyrB/ParE target with stellar preclinical results. Great thing about antibiotics and anti-infectives are that, if they show potency in in vitro or preclinical, then they show similar effect in the clinic too. They work on external target, bacteria, rather than human biology. All these preclinically proven drugs have to show is that they are safe in humans.
I personally believe that TSRX PPS will see tremendous potential in 2013.