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TOB

Re: cabel post# 74899

Thursday, 10/23/2014 6:14:00 PM

Thursday, October 23, 2014 6:14:00 PM

Post# of 403042
They announced the Primary Outcome Measure:



Can anyone help me to understand this:

,...when observed 2-3 days only,...?

Does that mean we do not know if we are equivalent at 28 days,..? -cabel




Here it is on the trial outline:


Primary Outcome Measures:

Early clinical response [ Time Frame: 48-72 hours after first dose of study drug ] [ Designated as safety issue: No ]

The primary efficacy outcome, early clinical response 48-72 hours after the first dose of study drug, will be determined in the ITT population. A subject will be considered a Clinical Success if 1) the lesion area has decreased by =20% compared to baseline and 2) no additional systemic antibacterials that are potentially effective against gram positive organisms have been administered. - Link



We have yet to hear on Secondary Outcome Measures, or the P-Value for statistical significance, or the specific numbers as noretreat pointed out.

PR was definitely a bit rushed.



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