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Biotech / Medical : Pharmos (PARS) -- Ignore unavailable to you. Want to Upgrade?


To: gfp927z who wrote (1315)11/25/2004 9:39:59 AM
From: Clarksterh  Respond to 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



To: gfp927z who wrote (1315)11/25/2004 2:31:11 PM
From: Tony van Werkhooven  Respond to of 1386
 
GFP - There were three distinct cohorts in the Phase II study.

I don't recall the results from memory. There was a problem with one of the cohorts - the Dex treated group had distinctly worse injuries.

I would suggest that you pose your question on the Yahoo Pharmos board - Address them to GSR-Seatle - I am confident that he has the information readily available.

Tony