Lets assume the initial halfway results are good, and that we even get FDA approval by the end of the year. Then what? No meaningful revenue until 2016 (as per company). Do you think the stock can be supported at 7, 10, 15 , etc without revenues or earnings? That's going to be the real issue IMO.
Like traderneo said, compare to other biotechs in similar stages. MDVN is the most obvious comparison. AMRN. Look at the Market Caps of Biotechs and compare. OREX, PSTI, ARRY, all in earlier phase trials and they are right there over CLSN.
Largest unmet need, fast track, rolling NDA, it sounds like they would like this on the market as soon as possible.
The other obvious potential is a huge buyout offer, if it is clear that ThermoDox works. That is always a factor in biotech.
Market caps are always based on futur revenues dear friend, check MDVN, AMRN and many others... You are totally wrong about first earnings in 2016. With a rolling NDA in 2013 and approval before year end 2013, revenues will start coming in 2014.