Replies to post #157964 on 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

[caravon]

It became very popular lately to make very predictions and trial designs based on 4-15 patients. Celldex is not alone. There are many such bio/pharma companies.

The most interesting part is that, using bogus "few patients statistical methods", there are numbers of researchers seriously speaking about stat significant results. However, refractive/salvage patients' treatment statistics is a totally different matter since there is close to zero placebo-treatment benefits.

[jq1234]

I'd agree extrapolating from the small number of very late stage of GPNMB+ TNBC to 2nd/3rd line vs an active comparator capecitabine increases the risk significantly. I was very comfortable with the small number in last line setting simply because comparator has almost no activity in this setting, and CDX011 is an active drug, thus chance of success is very high there. Now, CDX011 hasn't been tested in 2nd/3rd line setting, and it is going into ph3 in that setting. Hmmm...