Halozyme Therapeutics Inc (HALO)

[jamtomorrow2]

I note that the Company has offered absolutely no opinion on how good the PEG data was relative to the possibility of submitting an NDA based on that data. If we are talking PFS then I'd say the data was excellent albeit on a small sample size. Obviously on OS, which is not a primary endpoint to the Phase 3 trial, the data doesn't really show a clear good trend. So if that's the case tell us that you won't be submitting the NDA for another 2 years or more. I can't believe that not a single analyst even asked the question.

Helen did say that they'd passed the data on to the FDA. What exactly does that mean? The FDA aren't going to do anything with it without a request. So is HALO going to ask the FDA's opinion? I'm not sure that the FDA is into offering opinions on whether to file or not. File and we'll let you know in 12 months. And of course HALO and the FDA have history.

In view of the market's general misunderstanding of the so-called 'cherry-picked' data and the disappointing royalty figures and the continued out of control unfunded PEG trial costs a little clarity might be a good thing and doesn't cost a penny.