Halozyme Therapeutics Inc (HALO)

[Fred Kadiddlehopper]

Actually I have a question for FOTD:
On the other board there is a summary by Telecominvest of the issue of hazard ratio in the PEG studies which I quote here below. Is this an accurate rendition of the issues at hand? HR is not something that is yet within my ken.
Thanks!
-Fritz

There are two issues concerning the Hazard Ratio. One good, one not so good. You need to understand them.

1. The calculated hazard ratio from 202 interim data was 0.39 based on biopsy of tissue sample. This was very good. It basically meant that for every 10 high HA people in the control arm experiencing progression of disease, there were only 3.9 high HA people in the PEG arm progressing. Lower HR = Good.

When they went back and used the diagnostic to determine high HA, the Hazard Ratio increased to 0.48. Still good, but not as good as the earlier read. This indicates that there was some reassignment of high HA subjects due to the diagnostic. I'm hoping there will be a discussion of this on the call to clarify. I'm guessing that they were taking credit for PFS in a few low HA subjects that was reversed by the diagnostic.

2. The other issue is the application of a 0.59 Hazard Ratio in 301. This was agreed to with FDA, and considering the read on 201 at 0.48 HR, HALO is guaranteeing the achievement of the PFS primary endpoint.