Biotech Values

[DewDiligence]

>ISIS – 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.

Moreover, I reread the language in the PR and I do not see the ambiguity you alleged in your prior post. The relevant section of the PR says:

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“…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.”
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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.

(Bear in mind that a staggered patient-enrollment schedule makes it possible for a shorter survival time of one individual to result in a later death chronologically than a longer survival time in another individual. Many people get themselves confused by overlooking this point.)

There is nothing especially odd about a PR omitting a p-value for interim data in a phase-2 trial. The only inference you can draw is that (for the reason mentioned by PGS) the omitted p-value is not superlative. Regards, Dew