PGS,
I've listened to the CC and every single analyst congratulated the management team on the good/great results.
Ren Benjamin did raise the question of the 24-month data. Another analyst called the 24-month data "disturbing."
Both the CEO and Dr. Thornton argued that what is needed is survival at one year, and that the hazard ratio is the key statistic here for the FDA. They went on to say that the end of the curve is notoriously unreliable because of the few data points. But they argue that even if the curves come together at 24 months, all that means is that TNFerade does not cure the cancer, but that is not the point of the study. The main point they say is to extend survival at one year, and they have done that with at an outstanding hazard ratio. Dr. Thornton pointed out that Tarceva was approved on the basis of a hazard ratio that is not as good as TNFerade.
Doug Swirsky, CFO, said that they now have sufficient clear data to partner the drug.
Is all this pure spin, or does it have some validity?
Bladerunner