Halozyme Therapeutics Inc (HALO)

[jamtomorrow2]

Well what to make of all this eh! To tell us a few weeks ago that the PFS data would be ready in Q1 and now PFS is being dropped in favour of OS with results due in H2 - wow. So is this because PFS results maybe aren’t up to expectations. They’re blinded right? Well actually they’re not fully blinded because of the high level of AEs in PEG patients. HALO were pretty non committal on this meaning almost certainly that results aren’t as good as expected. But they did tell us that the PFS part of the trial was not halted for futility so they weren’t disastrous. But in my view there was no reason to make the switch as the FDA had said the OS trend would be sufficient to allow approval based on good PFS numbers. Now we are relying on OS. What a mess. And then there was the question about what treatments patients were on when the PFS period was up. This was up to the doctors and HALO has no influence on this. So that’s going to be a big factor in determining whether it’s PEG or the final treatment that is improving OS. So if PFS levels are disappointing but OR is good why would HALO be allowed to claim that that improvement is down to PEG when it could just as easily be down to different treatments after PFS is over. I can see this being a nightmare to get approval on. Contrary to what HALO are saying it is going to be way harder to get approval on OS than PFS when final treatments are all different.
I didn’t like the way HALO handled the call. Confusing everyone with complicated statistical stuff was just there to muddy the waters. You could tell that most of the analysts had absolutely no idea what HALO were talking about. That’s what HALO wanted.