The company has previously indicated a plan to partner, if they've now indicated otherwise I question whether they either couldn't find anyone interested that was willing to pay their price, or they intend to dilute dramatically to afford the effort. If they don't partner or contract for assistance, they'll be undertaking a job that they'll find overwhelming. I'm talking about dealing with the foreign equivalents of the FDA to gain approvals. Certainly many countries may approve based on FDA actions, but others won't. They will also be burdened with the logistics of distribution and sales worldwide which have extra burdens because of personalizing the drug for every patient.
I'm not a DNDN investor, but if you're correct, I believe much of the price growth that could have been expected from U.S. sales and partnering will be burned in gaining approvals elsewhere, and setting up a worldwide organization. Long term the profit may be greater, but will investors want to wait.
I may be wrong in terms of what they're doing, but then I wasn't wrong about the drugs ability to be approved. I urged caution in 2007 and was correct about that, but then I indicated I thought it would be approved on the new data, but admittedly thought it might be delayed. I'm happy the FDA didn't further delay it with some silly question, as they've been known to do, but then they did delay roughly 3 years. Perhaps some Change has come to the FDA, far more is needed IMHO.
Gary
