Halozyme Therapeutics Inc (HALO)

[jamtomorrow2]

So basically what she’s saying is that the PFS numbers will yet again be messy - just as they were from the Phase 2 trial. You’d have thought that they would have learned how to address this problem after the Phase 2 fiasco but apparently not.

The thing that’s difficult to grasp is that she seems to be saying that it’s the control arm that’s producing longer than expected PFS numbers caused by patients coming off PEG and going onto new treatments. If that’s correct surely that’s really bad for PEG - coming off it and going onto different drugs and subsequently coming up with higher than expected PFS numbers is surely bad for PEG. You’d logically think that if those control arm patients were followed through to death then their OS numbers would be higher than PEG. But I suspect that those patients’ OS data will be eliminated from the control arms’ OS numbers so as to make the PEG numbers look better. I can see the FDA issuing a CRL and demanding yet another trial as basically it’s all HALO’s fault for their very sloppy Phase 3 trial design. Helen could find herself out of a job for this mess.