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Biotech / Medical : Theravance - THRX -- Ignore unavailable to you. Want to Upgrade?


To: bio_kruncher who wrote (41)8/28/2006 1:36:10 PM
From: Biomaven  Respond to of 74
 
Many thanks bio kruncher - that all makes sense now.

Peter



To: bio_kruncher who wrote (41)8/28/2006 2:08:11 PM
From: DewDiligence_on_SI  Respond to of 74
 
In these studies, non-inferiority was needed to claim effectiveness. If the test of superiority in MRSA was conditional on first achieving non-inferiority overall then no alpha adjustment would be needed.

That’s the key to not exhausting additional alpha for the dual endpoints and it applies to many trials even where the superiority claim is based on the full ITT population; i.e., these trial protocols require a finding of non-inferiority in order for a finding of superiority to have force, which is consistent with the Hochberg correction:

investorshub.com

However, a trial protocol specified in an SPA is not required to use the Hochberg correction (as above), and hence there could be some cases where there are separate alphas for the two endpoints.