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?
My guess is that there is someone who understands. The reason I say this is that Alexion canceled their second ph iii as soon as the first one failed - indicating that they knew that the data from the ph ii's was not repeatable and that the ph iii failure was not just bad luck. The hard part is that Alexion hasn't really talked about the ph iii results - e.g. they were forced to change the endpoint in the ph iii and in so doing they discovered that CKMB reductions didn't correlate???
My guess is either a SoC change, an endpoint change or a patient enrollment change.
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