Biotech Values

[bladerunner1717]

PGS,

I'm sure you know better than I do. But the results won't be known until 2015, with an interim look at 80 events. The confirmatory OS study will start at that time. The design of the confirmatory trial worries me (from what very little I understand about this stuff). The confirmatory trial will be an all-comers trails, not just high-expressors. (The accelerated approval trial has to hit on EITHER ORR or PFS. The comparator arm is Xeloda.) I don't know much about this, as you well know, but I am concerned when the entry criteria changes from the accelerated approval trial to the confirmatory trial. When asked about this on the CC, Marucci said that they wanted to expand the indication. That's all well and good, but not at the potential cost of jeopardizing the approval. But I'll let the experts like you address that issue. I'll be out of the stock by then (2017). Like McBio, I don't like holding through binary events (although I did it on ACAD).

I think the Market may be undervaluing the pipeline, especially CDX-1127 and CDX-1135. Results on both are due out this year, and these could become value-drivers. We'll see.


Since you wanted your memory refreshed, here's a two-year chart on CLDX:

http://finance.yahoo.com/q/ta?s=CLDX&t=2y&l=on&z=l&q=l&p=e50%2Ce200&a=&c=&desktop_view_default=true


Bladerunner