PARD (mcbio) - I think all your points are excellent and perfectly valid. Regarding lack of a controlled trial and the possibility of the control arm doing better than expected, there is that possibility and that is exactly why I used the "assuming BSC survival is 14 weeks as expected". I think the difference between this trial and the numerous other trials where the control arm on SOC fared better than expected is that the primary endpoint is overall survival. There is no placebo effect as well. The trial is an open label trial monitored by a DMC so patients know whether they are getting pico or not. Based on the literature that I've read, the average survival period for patients with relapsed SCLC is around 12 weeks. Some state survival could be as low as 8 weeks. Since the control arm does not receive any type of chemo or any other treatment that will rid of the cancer cells I think there is very little chance that overall survival will exceed the average.
The phase II trials of picoplatin had a mixture of refractory, resistant and sensitive patients but the majority were not sensitive. The phase III trial includes a lot more sensitive patients and since those type are more responsive to platinum therapy, the assumption is that survival on the Pico arm will be a lot better than in the P II trials. The occurrence of the 320th event certainly points that way. The sensitive patients in the PII trials had an overall survival period of 36 weeks compared to the refractory ones who had only 26 weeks.
I am more concerned about other factors that I may not have thought about. I think the lack of a partner until now is both concerning and encouraging. Management has not diluted yet and financially the company is not sound so they need money. So it is encouraging that dilution has not occurred. On the other hand if the outcome is so obvious I also wonder why a partner hasn't swooped in yet. Management wants the best deal possible so they seem to be willing to wait, or so they say.
