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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 (1315)11/25/2004 9:39:59 AM
From: Clarksterh   of 1386
 
For the Phase 2 TBI study, did Pharmos release the actual data / detailed summary of the data (one that was more detailed than their press release)?

Yes. Sort of. They put out a paper combining 2 of the 3 arms. See the thread below for discussions of that paper and their retrospective culling of data.

Was the Phase 2 powered to show statistical significance?

A Phase II has a different purpose - to work through the bugs and determine how to size the phase iii. I don't really think they knew what they would find coming out of Phase II.

Also, in the Phase 3, does anyone know the % level of improvement they'll need in order to show statistical significance for the various endpoints?

Good question. 800+ patients is a lot. I suspect they could find even a 1/2 GOSE category improvement with stat sig, but I haven't worked the numbers.

BTW - first read your questions as being inre the P II CABG. But updated this post to correct for my misread.

Clark
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