It sounds like the RAC director is simply blowing his own...

It sounds like the RAC director is simply blowing his own trumpet by stating the obvious - of course the FDA has a higher tolerance for safety issues for oncology drugs candidates versus pain drugs. That's a very generic comment. If there was anything specific to PAR then I'm sure we'd all love to hear more about it. His example suggests that the FDA would have zero tolerance on safety for drugs that relieve pain. Not sure if that's entirely accurate. Let's say that 1 in 1000 patients do record kidney failure in the PPS arm of our Phase 3 trial. But kidney failure is recorded at a rate of 5 in 1000 patients in the placebo arm. Is his comment still valid then? So how it compares to placebo doesn't matter? In fact, it is totally unrealistic and uneducated to expect zero serious adverse events (SAEs) for the patient age population in question. If we look at Tanezumab's Phase 3 results - SAE's were recorded at a rate of 41 in 1000 patients in the active arm, and 24 in 1000 patients in the placebo arm. If the RAC director is correct, tanezumab should have zero chance of getting approved. Yet the FDA accepted their BLA, we will see what happens with that probably in March. Even the placebo is likely to be banned for all future use - SAEs at a rate of 24 in 1000 patients is clearly unacceptable.



There is a lot to like about drugs that could treat cancer and I hope they have all the success in the world with their's. But if we're here just to make generic comments, then there is also a lot not to like about oncology drug candidates based on the stats...which was conveniently not mentioned by him: