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Re: iwfal post# 41643

Wednesday, 02/07/2007 11:20:00 AM

Wednesday, February 07, 2007 11:20:00 AM

Post# of 257275
Iwfal,

Thanks for the answer.
My question was why was the huge difference between previous pahse III and the pivotal phase III? and your answer is that it would be nice to understand.
Does anybody understand?
And in general, why does this happen often?
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The pivotal alexion trial failed.
In the primary endpoint they had 0.069. I would not characterize that as bombed.
Had they had a larger n (e.g. 3000 like MCU's current trial) with similar outcome, or primary endpoint (like MCU's again)
their drug would be on market already.
Instead they scrapped it altogether. My bet is that they did not feel they were competitive against MC-1 at that point. Any other guess?

Incidentally for MCU according to the claim inclusion exclusion criteria is the same. Principal investigators are the same.
Most old sites repeat, and virtually all that contributed many subjects. I assume that these sites will provide a very substantial subset of patients. Of course there will be lot more new sites, as the site number is much larger in this trial.

Of course we do not know everything.

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