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Biotech / Medical : Pharmos (PARS)
PARS 2.700+13.6%Jan 21 4:00 PM EST
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To: gfp927z who wrote (1323)11/30/2004 6:52:47 PM
From: Clarksterh   of 1386
 
In the published Phase 2 results, they also break down neurological recovery based on the patient's GCS scores upon entry into the trial. At 6 months, the GCS 4-6 patients did phenomenally better than placebo, while the less seriously injured GCS 7-8 patients beat placebo, but a lot less dramatically. Let's say the Phase 3 has similar results, but the GCS 4-6 subgroup reaches statistical significance while the GCS 7-8 subgroup doesn't (and the combined GSC 4-8 group just misses).

Ran the numbers and have to change my answer. No, it is unlikely that if they still use GOS Good Outcome as the top category that they will reach stat sig even if they multiplied the number of participants in this group proportional to the overall trial enrollment expansion. And we know that this group is actually being expanded less. However, offsetting this is that they may use the GOSE top category (the top half of GOS Good Outcome) and that will probably be more differentiated. Who knows how much? Probably still not enough to hit stat sig all by itself.

BTW - Ran the numbers for the trial as a whole assuming exactly the same results as in the Phase II but with a different proportion of low GCS (more) to high GCS (fewer). Ridiculously low p values.

Clark
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