Replies to post #136914 on Biotech Values

[exwannabe]

CLDX, If I can but in ...

On the 011 P2B, I think everybody agrees that failure to be stat sig is not the end of the game.

I would say though that it needs to show more than "the same or better" as a point value. Something like 15% vs 5% would make me happy (and not be stat sig).

On India, the FDA will not balk just because of the India locations. They will keep a close watch on that though, so the danger is that the locations actually do have serious violations and anomalies.

[mcbio]

Clark or Mcbio: With respect to the Phase III Rindopepimut (CDX-110) in Glioblastoma EGFRvIII+, 8 out of the 33 trial locations are in India - any worries that the FDA might wet their diapers about any potential trial protocol violations? I would guess that India might be worse than Eastern Europe in this respect.

I'm long CLDX for 011, not 110. I view 110 as a fallback option, along with the rest of the pipeline, in the event that the Phase 2b results for 011 disappoint. But, I am of the opinion that the 011 results are the key potential value-driver for CLDX. Let's just hope the data comes through.

[iwfal]

CLDX -

So if I am reading this correctly they are saying that EGFRvIII positive status leads to longer survival which is completely the opposite of what CLDX/Dr. Sampson have claimed that being EGFRvIII positive is a highly poor prognostic factor for survival. I do not know enough about the science to judge who is right or if this was just an oddball journal article.

Oddball journal article. 79 patients and they ran a Cox Regression on 4 or 5 potential prognostics. Completely moronic. (vs the Pelloski paper cited by CLDX which is 650 or so and uses a much more sound methodology) That said:

1) One of my key areas of discomfort with CLDX is that they were strident in emphasizing the wonderfulness of their case matched trial comparator. Danger, danger! No case matched controlled trial with 17 patients is worth much of anything.

2) They have no randomized data and I haven't looked yet at all the historicals. So can't comment.

Note - one interesting piece of the paper you pointed to is that recurrent GBM typically does not have as much EGFRviii as the original tumor. This is important because one of the more interesting pieces of rindo data is that treated patients seem to clear EGFRviii upon recurrence. More research needed.

Clark