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Re: DewDiligence post# 69501

Thursday, 12/04/2008 11:07:56 PM

Thursday, December 04, 2008 11:07:56 PM

Post# of 257295
To be truly clear, they would have stated a p value and would have made it very clear whether or not all events had occurred in the control arm. I'm not sure if the fact that they seem to imply that is enough for me to pull the trigger on this one.

Nothing in the PR suggests that all deaths to date occurred in the control arm. This is an improper inference on your part.


Dew, I'm just not being clear on my point. I'm not inferring all deaths occurred in the control arm as I understand deaths have occurred in both arms. The question I'm seeking an answer for is whether or not all of the patients within the control arm have died. I know there are patients still alive in the OGX-011 arm because the PR clearly states that survival updates are needed before a mature median survival for the OGX-011 arm can be reported. Because the PR doesn't also state that survival updates are needed to determine median survival for the control arm, I'm curious if this implies that all patients in the control arm have died and we therefore have the median survival time at 16.9 months for the control arm.

…the Phase 2 randomized study in 82 patients with metastatic or locally recurring prostate cancer refractory to hormone therapy showed a median survival of 27.5 months for the patients in the OGX-011 arm and 16.9 months for patients in the control arm.

This is crystal clear: the median survival time for the deaths to date is 27.5 months in the treatment arm and 16.9 months in the control arm—a difference of 10.6 months mentioned earlier in the PR. The median survival time in each arm will change as the trial progresses because new deaths can occur with a survival time either above or below the tentative median.


Again, I know that 27.5 month number for the OGX-011 will change given that not all patients have died but I'm curious if that 16.9 month number for the control arm is static, which it would presumably be if all patients in that arm have died.



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