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Re: iwfal post# 142471

Wednesday, 05/23/2012 9:21:59 PM

Wednesday, May 23, 2012 9:21:59 PM

Post# of 257406
re; CLDX

Clark,


I respectfully disagree. I agree it is good data for randomized ORR data. But that modifier (ORR data) is important - ORR often doesn't translate well up the clinical benefit ladder to PFS and then OS



Dr. Vahdat seems to disagree with you. On the CC, she explicitly said that ORR, in this indication, maps very well with PFS.

Dr. Ron Garren says that CLDX will try to do a small, single-arm study with PFS as the primary endpoint under "accelerated approval." Simultaneously, CLDX will be doing a larger, randomized confirmatory trial. (This sounds so similar to ECYT--as well as the way the stock is responding, down 8% in AH on one million shares traded--that it's a bit eerie for two of my largest holdings. LOL) But CLDX needs a partner to do all this, Dr. Davis notwithstanding. I don't know if a potential partner needs to see the final data before committing. (I'd appreciate any thoughts on this final point.)


Bladerunner


Bladerunner

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