1. CLDX will pursue high-expressors of GPNMB in triple-negative breast cancer with OS as the primary endpoint in 3rd or 4th line therapy. This surprised me, because my understanding had been that that CLDX would pursue a PFS strategy in a small single-arm study. Marucci left the door open to this possibility, depending on what happens with the FDA meeting in early 1Q13. The patients in 3rd and 4th line therapy have such a terrible prognosis that Marucci thinks that 011 could very well show an OS benefit rather quickly. Triple-negative, high-espressors are about 6% of the total breast cancer population and Marucci thinks this is a good market to target.
Thanks. I listened to the call rather quickly and didn't catch all of these points. If they are indeed focused on 3rd and 4th line, that could well signal no partner on hand as I would think a big pharma partner would be inclined to at least also pursue earlier lines. That said, is the current trial in 3rd/4th line? If so, perhaps I'm reading too much into this.
5. Important 011 data in breast cancer will be presented this Saturday at SABC.
This is what I'm anxious to see. This will include both an update on PFS and preliminary OS data. This is a pretty big event for CLDX I think. Hope the data is good. I intend to hold my position in full through this, for better or worse.
7. No word on partnerships at all. Not a good sign, IMO.
Most important thing near-term I think is that data on Saturday. Let's see what that brings.