The company will definitely file an NDA on Rubitecan for patients who have failed Gemzar.
It cannot be stressed strongly enough that many cancer drugs have more substantial off-label sales than they do in their approved indications. Gemzar is itself an example of this, it generates more revenue in off-label non-pancreatic cancer patients than it does in pancreatic cancer patients. Thus, getting Rubitecan approved ASAP is of primary importance.
Secondly, Rubitecan was been very widely studied, the current trials are the largest ever in pancreatic cancer patients, and the company has (and will continue to) actively publish and present their findings. Too, virtually every major cancer center has been involved in a Rubitecan trial. In short, virtually every oncologist knows about it (and/or will know about it when they file) and will not hesitate to use it for off-label purposes. Finally, SUPG will likely have data available from both the salvage Ph3 as well as the head-to-head vs. Gemzar Ph3 by the time they launch the drug officially. And, the FDA allows them to present this data when they make calls on oncologists.
In sum, Rubitecan WILL be a blockbuster drug, and is dependent solely on getting to the market ASAP. Once on market, the data from additional studies coupled with oncologists' familiarity with the drug and the constant flow of new data will ensure widespread usage.
I continue to believe that the company remains one of the best buying opportunities in biotech seen in the past several years.