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Re: iwfal post# 47504

Sunday, 05/27/2007 11:43:02 AM

Sunday, May 27, 2007 11:43:02 AM

Post# of 252588
cypb------They do have to execute anothor phase 3 trial before seeking approval correct?

a) Pain Label - almost certainly not. They just barely missed the pain composite endpoint on the first ph 3 and were very stat sig on the one that just finished


This is not horseshoes. Barely missed is a miss. This is not a life threatening disease where one phase three could be sufficient. This is pain which is caused by ... that's right, no one knows.

I am unclear how they or you, can be so sure they can get the drug approved on one trial that worked. Something doesn't sound right to me.

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