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Re: iwfal post# 1422

Tuesday, 10/31/2006 12:20:02 PM

Tuesday, October 31, 2006 12:20:02 PM

Post# of 12660
(Are we breaking out this morning ?)

Well I shouldn;t have generalized. I was thinking that this is one of the "long" cancers (unlike NCSCLC or Pancreatic, etc).

I was looking at ALTH recently. Turning it over on the IV board, I was surprised to see that in their earlier phase III they had a HR of around 1.40 and a p-value of 0.15 in the TT.
Great, huh ? Well no, that was their Interim Look. By the time the Final Look came around, it was approx HR = 1.20 and a p-value of 0.08. To me that makes sense, these patients still have metastatic disease - the more that are alive on one arm, the more "candidates" there are for events. Nevertheless, the new trial is designed just like the old one - and just as you say, the Final Look is around the 75% mark. I will be giving it a pass unless the stock is like a buck or two then.

But getting back to 9902b - we increased the trial size, and allowed sicker patients. Plus we believe that all-cause mortality (including the rigors of old age) blurs the benefit. So I am going to make a wild guess that it's indeed in the 60s.

Maybe even at around 60% (300 events as a round number - that's my WAG). Interim look at 45% - 50% of events (I think Gold confirmed there is one).

I haven't worked on this, It will be interesting what p3analyze comes back with. Of course then I'm sure you have a HR and maybe even a guess at an interim analysis number in mind. Prolly been posted before here too, mea culpa if I missed it.





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